Presentation: Warning Letters

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Presentation: Warning Letters
5/24/13
2013 > Hillestad Pharmaceuticals USA, Inc. 4/17/13
Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters
Inspections, Compliance, Enforcement, and Criminal Investigations
Hillestad Pharmaceuticals USA, Inc. 4/17/13
Public Health Service
Food and Drug Administration
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
Departm ent of Health and Hum an Services
April 17, 2013
WARNING LETTER
via UPS OVERNIGHT
Refer to MIN 13 – 16
Donald L. Hillestad
President
Hillestad Pharmaceuticals USA, Inc.
178 U.S. Highway 51 North
Woodruff, Wisconsin 54568
Dear Mr. Hillestad:
From July 25 – 27, 2012, an investigator from the Food and Drug Administration (FDA) conducted an
inspection of your dietary supplement manufacturing plant at 178 U.S. Highway 51 North, Woodruff,
Wisconsin. The inspection identified a number of significant violations of the Current Good Manufacturing
Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations Part 111 (21 CFR
Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of
section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(g)(1), in that
the dietary supplements have been prepared, packed, or held under conditions that do not meet the CGMP
regulation for dietary supplements.
We received your letters dated August 16, September 12, October 2, December 19, 2012, and February 27,
2013, responding to the form FDA-483, Inspectional Observations, which we issued on July 27, 2012. We
address the adequacy of your responses following each of your remaining significant violations below.
Your significant violations include:
1.
You did not ensure that the tests or examinations you identify to demonstrate that you have met the
established specifications are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1).
Specifically, you use (b)(4) for all identity testing; however, the method or your use of standard
reference materials is inappropriate as follows:
a.
You use (b)(4) for all identity testing based on the initial lot of product received of an ingredient
without confirming the identity of the initial lot. The initial lot becomes your reference standard for future
lots.
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2013 > Hillestad Pharmaceuticals USA, Inc. 4/17/13
b.
You have established a specification, Hit Quality Index (HQI) of at least (b)(4) as compared to the
reference standard, for all incoming materials. However, when challenged, a sample of product was shown
to have at least (b)(4) possible matches to the reference standards at a specificity of over (b)(4). Any of
these (b)(4) could have been accepted as the tested material using the method and specifications
established.
c.
You reported that almost all vitamins and minerals show a match at (b)(4) HQI or higher but you have
never re-evaluated your specification limit or determined if a more stringent limit is appropriate.
d.
As previously stated, you use (b)(4) for all identity testing but you have not demonstrated that this
is an appropriate test to identify probiotic species. We note that the (b)(4) is limited in its capability to
adequately identity live strains of organisms.
We have reviewed your response and find it inadequate because you failed to provide documentation of the
specific steps you will take to ensure compliance.
2. You did not verify that your finished batch of dietary supplement meets product specifications for
identity, purity, strength, composition, and for limits on those types of contamination that may adulterate
or that may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR
111.75(c). Specifically, you have established specifications for strength and composition on your product,
Acidophilus with Pectin; however, your means of verifying whether specifications are met are “based on
input,” as in your operators have identified that they have added the ingredients to the batch of product.
Ensuring that an ingredient is added to the batch of product does not provide adequate assurance that the
finished product specifications are met. Furthermore, although you did conduct finished product testing on
your Iron Tone Plus and Folic Acid Tablets for vitamin C content, you did not provide adequate
documentation of your basis for determining that compliance with the specifications selected would ensure
that your finished batch of the dietary supplement meets all product specifications, as required by 21 CFR
111.75(c)(3). For example, you did not provide documentation for your basis for determining that meeting
the specification for vitamin C in your Iron Tone Plus product would ensure that the specifications for iron
and vitamin E are met. Moreover, iron and vitamin E are likewise verified “based on input” which, as stated
above, is not an appropriate finished product test.
We have reviewed your response letter dated February 27, 2013, but we are unable to determine the
adequacy of your response. You state that you have discontinued your Acidophilus product and replaced it
with a stronger Acidophilus product without pectin, and that you have established a specification for
Acidophilus at the finished batch stage that you will verify through finished product testing. However, you
did not provide the established specification, nor did you provide an explanation of the finished product
testing you plan to conduct. We have also reviewed the blending study that you submitted with your
February 27, 2013, response letter, but it does not address the components that are in the products that
were reviewed during the inspection. Furthermore, your blending study failed with respect to Biotin and you
did not provide sufficient detail for us to review the study; therefore, your response is inadequate.
We acknowledge that you indicated that your Garlic/Goldenseal/Echinacea and Naticor products cannot be
tested at the finished batch stage due to interference, that these products are not currently being
manufactured, and that prior to manufacturing the products in the future, you will prepare the necessary
documentation exempting the product from verification testing under 111.75(d)(1). We note that our
investigators will verify compliance under 111.75(d)(1) at the next inspection.
3. Your Master Manufacturing Records (MMRs) did not contain written instructions for the required elements
necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.210. For example,
your MMR for your Acidophilus with Pectin failed to include:
a. Corrective action plans for use when a specification is not met, 21 CFR 111.210(h)(5);
b. Procedures for sampling and a cross-reference to procedures for tests or examinations, 21 CFR
111.210(h)(2)].
We have reviewed your response and find it inadequate because you failed to provide a copy of the MMRs
that include corrective action plans.
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility
operates in compliance with the Act and all applicable FDA regulations, including the CGMP regulation for
www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm349023.htm
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2013 > Hillestad Pharmaceuticals USA, Inc. 4/17/13
dietary supplements. We may take further action if you do not promptly correct these violations. For
instance, we may take further action to seize your products and/or enjoin your firm from operating.
You should notify this office in writing within 15 working days of receipt of this letter of the steps that you
have taken to correct the above-listed violations and to assure that similar violations will not recur. If
corrective action cannot be completed within 15 working days, please state the reason for the delay and
the timeframe within which the corrections will be made.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s
costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections
conducted subsequent to an inspection that identified non-compliance materially related to a food safety
requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspectionrelated costs means all expenses, including administrative expenses, incurred in connection with FDA’s
arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the reinspection fees, 21 U.S.C. § 379j-31(a)(2)(B). FDA will assess and collect fees for re-inspection-related
costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to
cover any re-inspection-related costs.
Address your reply to the U.S. Food and Drug Administration, 250 Marquette Avenue, Suite 600,
Minneapolis, MN 55401, Attention: Tyra S. Wisecup, Compliance Officer.
Sincerely,
/S/
Michael Dutcher, DVM
Director
Minneapolis District
Page Last Updated: 04/29/2013
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www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm349023.htm
3/3
5/24/13
2013 > Natures Health Options LLC 4/2/13
Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters
Inspections, Compliance, Enforcement, and Criminal Investigations
Natures Health Options LLC 4/2/13
Public Health Service
Food and Drug Administration
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770
Departm ent of Health and Hum an Services
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-13-15
April 2, 2013
Joseph A. Buenconsejo
President
Natures Health Options, LLC.
P.O. Box 294041
Boca Raton, FL 33429-4041
Dear Mr. Buenconsejo:
This letter is in response to the U.S. Food and Drug Administration (FDA) investigation of your firm Natures Health Options, LLC located at 6200 NW 2nd Ave, Unit
311, Boca Raton, Florida. FDA conducted its investigation from July 23, 2012 to July 25, 2012, at the FDA Boca Raton Resident Post.
During the investigation, you informed our investigator that your firm distributes Charantea Bitter Melon Ampalaya in 500 mg capsules and as tea bags; these
products are labeled as dietary supplements. In addition, you informed our investigator that your firm has entered into agreements with contract manufacturers to
manufacture these products and that your firm conducts holding and distribution operations for these products.
Based on our review, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.
You may find the Act and FDA's regulations through links in FDA's home page at www.fda.gov1.
Unapproved New Drug Violations
Based on a review of your product labeling, including your website, www.charanteausa.com, we have determined that your product, Charantea Ampalaya is promoted
for conditions that cause it to be a drug under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your website establish that the
product is a drug because it is intended for use in the cure, mitigation, treatment or prevention of disease. The marketing of these products with these claims
violates the Act. The following is an example of a claim on your website:
“Charantea…blood sugar-lowering properties.”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the
Act [21 U.S.C. § 321(p)]. A new drug may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21
U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Further, your product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore,
adequate directions for use cannot be written so that a layperson can use these products safely for their intended uses. Thus, the labeling fails to bear adequate
directions for the products’ intended uses, causing the products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of
misbranded drugs into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
Dietary Supplement CGMP Violations
In addition, even if your product is not an unapproved new and misbranded drug, the Charantea Bitter Melon Ampalaya products packaged in 500 mg capsules would
be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that the products have been prepared, packed, or
held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements regulations, under Title 21, Code of Federal Regulations (CFR), Part 111 [21 CFR Part 111].
We received your written response, dated July 31, 2012, concerning our investigator’s observations noted on the Form FDA 483, List of Observations, that was issued
to you on July 25, 2012. We address your response after the applicable violation, noted below.
Specifically, during our inspection, our investigators observed the following:
1.
Your firm failed to make and keep written procedures for the responsibility of quality control operations,including written procedures for conducting a material
review and making a disposition decision, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). .Your firm's quality control personnel must approve for release, or
reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h). You
provided no written procedures for the approval and release of your dietary supplements by the quality control personnel.
As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your
firm’s name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary
supplement products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790 (Jun. 25,
2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of the dietary supplement into interstate commerce in its final form for distribution to
consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with
dietary supplement CGMP requirements.
Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to
ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement
CGMP requirements, see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S.
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658, 672 (1975) (holding that criminal liability under the FD&C Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and
power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations
of the FD&C Act). In particular, the FD&C Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate
commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. §§ 342(g)
and 331(a)). Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging and labeling operations for it is responsible
for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary
supplement CGMP operations.
You must establish a system of production and process controls ensure the quality of the dietary supplement and that the dietary supplement is packaged and
labeled as specified in the master manufacturing record (21 CFR 111.55). You must establish and follow written procedures for the responsibilities of the quality
control operations (21 CFR 111.103). The quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the
quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR
111.105). Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21
CFR 111.127(h) and 111.140(b)(2)). However, you provided no documentation of the quality control review to ensure the quality of the dietary supplements you
distribute and that they are packaged and labeled according to the master manufacturing record.
We have reviewed your response dated July 31, 2012 and determined it to be inadequate in that you did not provide documentation of written procedures for the
quality control operations and the implementation of these procedures. Additionally, we note that you stated you will meet with your contract manufacturers to
ensure that written procedures for quality control are in place; while your quality control procedure may include ensuring your contract manufacturers establish
written procedures for quality control, the regulation requires your firm to establish your own quality control procedures to ensure the quality of your product that
you hold and distribute. Therefore, to be compliant with the regulation, your written quality control procedures must address your holding and distribution operations,
including the approval and release of your dietary supplements into interstate commerce, in addition to the items you affirm you will correct in your letter.
2.
Your firm failed to make and keep written procedures for product complaints, as required by 21 CFR 111.570(b)(1). Specifically, your firm did not have written
procedures for the handling of product complaints regarding the dietary supplement products you distribute and for adequately investigating complaints and
documenting the findings of an investigation and follow-up.
We have reviewed your response dated July 31, 2012 and determined it to be inadequate because you failed to outline the specific steps you will take to address this
deviation.
3.
Your firm failed to make and keep written procedures for returned dietary supplements, as required by 21 CFR 111.535(b)(1). Specifically, you did not have
written procedures for handling any returned dietary supplements, including procedures for handling returned dietary supplement that must be destroyed or otherwise
suitably disposed of in accordance with 21 CFR 111.515, and for returned dietary supplement that may be salvaged in accordance with 21 CFR 111.520.
We have reviewed your response dated July 31, 2012 and determined it to be inadequate because you failed to outline the specific steps you will take to address this
deviation.
4.
Your firm failed to establish written procedures for holding and distributing operations, as required by 21 CFR 111.475(b)(1). Specifically, you indicated to our
investigator that you pick up fully labeled, packaged, and ready for shipment finished product and then you subsequently ship to your customers. Therefore, your firm
holds and distributes dietary supplement products and you must have written procedures for these manufacturing operations.
We have reviewed your response dated July 31, 2012, and have determined it to be inadequate. You state in your letter that you will ensure that your contract
manufacturers for Tea and Vegetarian Caps establish and maintain written procedures for holding and distribution. Although your contract manufacturers must
maintain written procedures for holding and distributing, your firm must maintain written procedures for holding and distributing dietary supplement product. In
addition, you did not include a defined date when you will have these procedures in place.
The violations mentioned above are not intended to be an all-inclusive list of violations that exist in connection with your products and their labeling. It is your
responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to do so may result in enforcement action
without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332
and 334].
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related
costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement
of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses,
incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21
U.S.C. § 379j-31(a)(2)(B)). FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted
in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related
costs.
We note that your website, www.charanteausa.com, contains statements that represent Charantea Ampalaya tea as a conventional food. For example, statements
include:
“Those who drink the tea after meals as a substitute for other beverages have achieved better overall health . . ..” (quoting Dr. Reynaldo Salinei)
“Taken as tea, Charantea is a great alternative to coffee or traditional teas . . ..”
“Instead of coffee or sugary drinks to cap your meals, make Charantea your healthy after-meal beverage.”
“Enjoy hot as a simple traditional tea, or over ice as a cool drink. Add flavor with a twist of lime and some sweetener.”
Section 201(ff)(2) of the Act [21 U.S.C. § 321(ff)] states, in part, that the term “dietary supplement” means a product that “is not represented for use as a
conventional food.” A product that is labeled as a dietary supplement, cannot also be represented for use as a conventional food. If a product is labeled as a dietary
supplement but does not meet the definition of a dietary supplement, e.g., because it is represented for use as a conventional food, the product is misbranded within
the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1) in that the description of the product as a dietary supplement is false and misleading. Further,
the introduction or delivery for introduction into interstate commerce, or causing thereof, of such misbranded products is prohibited under section 301(a) of the Act.
[21 U.S.C. § 331(a)]. Therefore, if you want to market your Charantea Ampalaya Tea as a dietary supplement, the product cannot be represented for use as a
conventional food (nor, as stated earlier, promoted for conditions that cause it to be a drug) and, among other requirements, must meet dietary supplement CGMP
requirements in 21 CFR Part 111.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to
correct the violations noted above. You should include in your response, documentation and any other useful information that would assist us in evaluating your
corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining
violations.
Please send your reply to the Food and Drug Administration, Attention: Carla A. Norris, Compliance officer at 555 Winderley Place, Suite 200, Maitland, Florida 32751.
If you have questions regarding any issues in this letter, please contact Ms. Norris at (407) 475-4730.
Sincerely,
/S/
Emma R. Singleton
Director, Florida District
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2013 > Natures Health Options LLC 4/2/13
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Email FDA
For Government For Press
Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News &
Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive
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5/24/13
2013 > Body Systems Inc. 4/8/13
Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters
Inspections, Compliance, Enforcement, and Criminal Investigations
Body Systems Inc. 4/8/13
Public Health Service
Food and Drug Administration
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770
Departm ent of Health and Hum an Services
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-13-16
April 8, 2013
Mrs. Mary F. Davis-Rossi
Owner
Body Systems, Inc.
4768 Bakersfield Ct.
Winter Springs, FL 32708
Dear Mrs. Davis-Rossi:
From October 18-22, 2012, the U.S. Food and Drug Administration (FDA) inspected your facility located at
4768 Bakersfield Ct., Winter Springs, Florida. During the inspection, you informed our investigator that your
firm has entered into agreements with other manufacturers to manufacture dietary supplement products
under your firm’s name. Based on our inspection and subsequent review of your product labeling, we found
serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You
may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov1.
We received your written response dated October 26, 2012, addressing the observations cited to your firm
on the Form FDA 483, Inspectional Observations, issued on October 22, 2012. We have reviewed your
response, and we address your corrective actions below. Your significant violations are as follows:
Unapproved New Drug Violations
We have reviewed the labeling of your products collected at the inspection and your websites located at
www.bstcatalog.com and www.bodysystemsinc.com in October 2012 and determined that your Joint-Ortho
Care and Seven Flowers BP products are promoted for conditions that cause the products to be drugs
under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your website
establish that the products are drugs because they are intended for use in the cure, mitigation, treatment,
or prevention of disease. The marketing of these products with these claims violates section 505(a) of the
Act.
Examples of some of the claims observed on your website include, but are not limited to, the following:
Joint-Ortho Care
www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm351883.htm
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2013 > Body Systems Inc. 4/8/13
“…Arthritis Aid…”
“Over 16 million Americans suffer from…arthritis and osteoarthritis, degenerative diseases of the
Teflon-like cartilage that cushion joints. JOINT-ORTHO CARE…works to repair & revitalize damaged or
worn connective tissue & cartilage.”
Seven Flowers BP
“Seven Flowers is an anti-hypertensive Chinese herbal remedy that may nutritionally help lower blood
pressure without the usual side effects of many blood pressure medications.”
Your products identified aboveare not generally recognized as safe and effective for the above referenced
uses and therefore, the products are “new drugs” under section 201(p)(1) of the Act [21 U.S.C. § 321(p)
(1)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in
section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data
submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your Seven Flowers BP product is offered for a condition that is not amenable to self-diagnosis
and treatment by individuals who are not medical practitioners; therefore, adequate directions for use
cannot be written so that a layperson can use this drug safely for its intended purpose. Thus, your Seven
Flowers BP product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the
labeling for this drug fails to bear adequate directions for use. The introduction of a misbranded drug into
interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
Dietary Supplement CGMP Violations
The October 18-22, 2012 inspection of your facility revealed that you failed to comply with the Current
Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal
Regulations, Part 111 (21 CFR Part 111). These violations cause your Liquid Colloidal Minerals to be
adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that it has been
prepared, packed or held under conditions that do not meet the CGMP regulations for dietary
supplements. Additionally, even if your Joint-Ortho Care were not an unapproved new drug, it would be an
adulterated dietary supplement within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]
in that it has been prepared, packed or held under conditions that do not meet the CGMP regulations for
dietary supplements.
During the inspection, you informed our investigator that you contract the production of your product labels
with another firm and that once sent to you, you ship the labels to your contract manufacturer. You also
informed our investigator that you are responsible for all content and any changes made to product labels.
As a distributor that contracts with other manufacturers to manufacture, package, or label dietary
supplements that your firm releases for distribution under your firm’s name, your firm has an obligation to
know what and how these activities are performed so that you can make decisions related to whether the
product conforms to established specifications and whether to approve and release the product for
distribution [72 Fed. Reg. 34752, 34790 (June 25, 2007)]. Your firm introduces or delivers, or causes the
introduction or delivery, of the dietary supplement into interstate commerce in its final form for distribution
to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of
the production of that product are in compliance with dietary supplement CGMP requirements.
Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the
same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into
commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary
supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining
that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance
of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding
that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested
with the responsibility, and power commensurate with that responsibility, to devise whatever measures are
necessary to ensure compliance with the Act” can be held accountable for violations of the Act). In
particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery
or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for
failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. §§ 342(g) and 331(a)). Thus,
a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and
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labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply
with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement
CGMP operations.
Our investigators observed the following CGMP violations during the inspection:
1.
Your firm failed to implement a system of production and process controls that covers all stages of
manufacturing, packaging, labeling, and holding of dietary supplement to ensure the quality of the dietary
supplement and that the dietary supplement is packaged and labeled as specified in the master
manufacturing record, as required by 21 CFR 111.55. Specifically, you do not have a system of production
and process controls to ensure the quality of your dietary supplements that you receive from your contract
manufacturers and that your dietary supplement products are labeled as specified in the master
manufacturing record.
2.
Your firm failed to establish the following specifications related to the labeling of your dietary
supplements:
Your firm failed to establish a specification or a point, step or stage in the manufacturing process
where control is necessary to ensure the quality of the dietary supplement, and that the dietary
supplement is labeled as specified in the master manufacturing record, as required by 21 CFR
111.70(a).
Your firm failed to establish specifications for dietary supplement labels (label specifications), as
required by 21 CFR 111.70(d).
Your firm failed to establish specifications for the labeling of the finished packaged and labeled dietary
supplements, including specifications that ensure that you applied the specified label, as required by
21 CFR 111.70(g).
We reviewed your response letter, dated October 26, 2012, and have determined that your response is
inadequate. Your response letter does not address the absence of specifications cited in observation 1 of
the FDA Form 483.
3.
Your firm failed to make and keep written procedures for the responsibilities of the quality control
operations, including written procedures for conducting a material review and making a disposition decision,
as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). The quality control personnel must ensure that
your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary
supplement and that the dietary supplement is packaged and labeled as specified in the master
manufacturing record (21 CFR 111.105). Further, you must have documentation of the quality control
personnel review and approval for release, or rejection, of any packaged and labeled dietary supplement for
distribution, as required by 21 CFR 111.127(h) and 111.140(b)(2). However, you provided no written
procedures for, or documentation of, the quality control review to ensure the quality of the dietary
supplements you distribute and that they are packaged and labeled according to the master manufacturing
record. Moreover, your firm has failed to perform the following quality control operations related to your
labeling, holding and distributing operations:
Conduct quality control operations for labels before use in the manufacture of a dietary supplement,
including reviewing all received records for labels [21 CFR 111.120(a)]. You indicated that you do not
examine incoming finished product labels that you receive prior to shipping them to your contract
manufacturers to have the labels applied to your products.
Perform quality control operations for labeling operations, including reviewing and approving all records
for label operations [21 CFR 111.127(c)].
Make and keep required quality control records in accordance with the records and recordkeeping
requirements [21 CFR 111.140(a)].
We have reviewed your response letter, dated October 26, 2012, and have determined your response to be
inadequate. Your response did not specifically address how you will establish and identify your quality
control operations. In addition, you did not provide a timeline for corrective action. The regulations require
your firm to establish written procedures for the responsibilities of the quality control operations, to ensure
the quality of the product you label, hold, and distribute.
Your response indicated you would be putting in place a written procedures manual for holding and
distributing operations, for complaint operations, for packaging and labeling operations, and for returned
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dietary supplements. However, you did not specify any corrective action for the failure to establish written
procedures for quality control. In addition, you did not provide a copy of the written procedures, or include
a timeline for implementation of your corrective actions. We are therefore unable to determine the
adequacy of your corrective actions.
4.
You firm failed to prepare and follow a master manufacturing record (MMR) for each unique
formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in
the finished batch from batch to batch, as required by 21 CFR 111.205(a). Labeling is considered a
manufacturing operation. You must prepare an MMR that covers the labeling operations of your firm.
Furthermore, you must make and keep batch production records (BPRs) in accordance with the
recordkeeping requirements of 21 CFR Part 111, in accordance with 21 CFR 111.255(d).
We have reviewed your response letter, dated October 26, 2012, and have determined your response to be
inadequate. Your response did not address the requirement to prepare and follow an MMR for your firm’s
labeling operations. Your response states that you are working with your contract manufacturers to receive
a copy of an MMR one time a year and that you have “requested batch records for each shipment received
and COA.” While your proposed corrective actions are important to partially satisfy the requirements of the
operations conducted by your contract manufacturers, it does not satisfy the requirement that your firm
create an MMR for the labeling operations of your firm.
5.
Your firm failed to establish written procedures for holding and distributing operations, as required by
21 CFR 111.453. Specifically, your firm has not established written procedures, detailing the required
operations to conduct when holding and distributing dietary supplement products, including, but not limited
to the following:
Holding components and dietary supplements under appropriate conditions of temperature, humidity,
and light so that the identity, purity, strength, and composition of the components and dietary
supplements are not affected, as required by 21 CFR 111.455(a).
Holding the packaging and labels under appropriate conditions so that the packaging and labels are
not adversely affected, as required by 21 CFR 111.455(b).
Holding labels under conditions that do not lead to mix-up, contamination, or deterioration labels, as
required by 21 CFR 111.455(c).
Holding reserve samples of dietary supplements in a manner that protects against contamination and
deterioration, as required by 21 CFR 111.465(a).
Retaining reserve samples for 1 year past the shelf life date (if shelf life dating is used), or for 2 years
from the date of distribution of the last batch of dietary supplements associated with the reserve
samples, for use in appropriate investigations, as required by 21 CFR 111.465(b).
We have reviewed your response letter, dated October 26, 2012, and have determined your response to be
inadequate. Your response stated that you will be putting in place written procedures for holding and
distributing operations; however, as you did not provide a copy of the written procedure, nor did you
include a timeline for implementation, we are unable to determine the adequacy of your response.
6.
Your firm failed to establish written procedures for product complaints, as required by 21 CFR
111.553. Specifically, your firm has not established written procedures for the handling of product
complaints regarding the dietary supplement products you distribute and for adequately investigating
complaints and documenting the findings of an investigation and follow-up.
We have reviewed your response letter, dated October 26, 2012, and have determined your response to be
inadequate. Your response stated that you will be putting in place written procedures for complaint
operations; however, as you did not provide a copy of the written procedure, nor did you provide a timeline
for implementation, we are unable to determine the adequacy of your response.
7.
Your firm failed to establish written procedures for returned dietary supplements, as required by 21
CFR 111.503.
We have reviewed your response letter, dated October 26, 2012, and have determined your response to be
inadequate. Your response stated that you will be putting in place written procedures for returned dietary
supplements; however, as you did not provide a copy of the written procedures, nor did you provide a
timeline for implementation, we are unable to determine the adequacy of your response.
Misbranding Violations
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Your Liquid Colloidal Minerals dietary supplement product is misbranded under section 403 of the Act [21
U.S.C. § 343] and the regulations implementing the food labeling requirements of the Act, which are found
in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101).
1.
Your Liquid Colloidal Minerals product is misbranded within the meaning of section 403(s)(2)(B) of the
Act [21 U.S.C. § 343(s)(2)(B)] because the label fails to identify the product by using the term “dietary
supplement” as a part of the statement of identity, except that the word “dietary” may be deleted and
replaced by the name of the dietary ingredients in the product or an appropriately descriptive term in
accordance with 21 CFR 101.3(g).
2.
Your Liquid Colloidal Minerals product is misbranded within the meaning of section 403(q)(5)(F) of the
Act [21 U.S.C. § 343(q)(5)(F)] because your label incorrectly lists dietary ingredients as “other ingredients”
outside the Supplement Facts box. For example, Aloe Vera is a dietary ingredient that should be listed inside
the Supplement Facts box in accordance with 21 CFR 101.36(b)(3).
3.
Your Liquid Colloidal Minerals product is misbranded within the meaning of section 403(i)(2) of the Act
[21 U.S.C. § 343(i)(2)] because the label fails to list all (b)(2)-dietary ingredients listed in 21 CFR 101.9(c)
(8)(iv) or (c)(9) that are contained in your product in accordance with 21 CFR 101.36(b)(2)(i). For
example, you make claims on your label that your Liquid Colloidal Minerals product contains “TRACE
MINERALS: Calcium, Chromium, … Selenium, Chloride, … Magnesium, Copper, Manganese, … Molybdenum, …
Sodium, … Iodine, … Zinc”. These minerals shall be declared in accordance with 21 CFR 101.36(b)(2)(i)
when they are added to the product for purposes of supplementation, or when a claim is made about them.
Their listing on the product label is a claim about them being present in the product.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in
connection with your products. You are responsible for investigating and determining the causes of the
violations identified above and for preventing their recurrence or the occurrence of other violations. It is
your responsibility to ensure that your firm complies with all requirements of federal law and FDA
regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct
these violations may result in legal action without further notice, including, without limitation, seizure and
injunction.
We also offer the following comments:
1.
Your firm includes expiration dates on the labels for your dietary supplement products. You stated to
our investigator that you do not have any supporting studies and that you do not know if your contract
manufacturers have such studies. Any expiration date you place on a product label should be supported by
data that demonstrates the product’s shelf life [see 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)].
2.
Your Seven Flowers BP does not bear or contain labeling as a dietary supplement, nor is the product
represented for use as a conventional food. Section 201(ff)(1) of the Act[21 U.S.C. § 321(ff)(1)], in part,
defines “dietary supplement” as a product “intended to supplement the diet that bears or contains [a
botanical extract],” and which product “is not represented for use as a conventional food.” The list of
product contents for Seven Flowers BP consists exclusively of various flower extracts, and the “suggested
use” portion of the product label states, “Take 3 to 6 tablets daily when under stress. No more than 12
tables per day.” Based on this information, it appears that Seven Flowers BP is intended to be marketed as
a dietary supplement. Therefore, even if Seven Flowers BP were not marketed in a manner so as to make
the product a “new drug” under section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]:
It would be a misbranded dietary supplement within the meaning of section 403(s)(2)(B) of the Act
[21 U.S.C. § 343(s)(2)(B)] because the label fails to identify the product by using the term “dietary
supplement” as a part of the statement of identity, except that the word “dietary” may be deleted
and replaced by the name of the dietary ingredients in the product or an appropriately descriptive
term in accordance with 21 CFR 101.3(g).
It would be a misbranded dietary supplement within the meaning of section 403(q)(5)(F) of the Act
[21 U.S.C. § 343(q)(5)(F)] because the label fails to include a “Supplement Facts” panel as required
by 21 CFR 101.36.
It would be an adulterated dietary supplement under section 402(g)(1) of the Act [21 U.S.C. § 342(g)
(1)], in that it has been prepared, packed or held under conditions that do not meet the CGMP
regulations for dietary supplements.
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The introduction or delivery for introduction into interstate commerce, or causing thereof, of such
misbranded and adulterated products is prohibited under section 301(a) of the Act. [21 U.S.C. § 331(a)].
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific
steps that you have taken to correct violations. Include an explanation of each step being taken to prevent
the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective
action within fifteen (15) working days, state the reason for the delay and the time within which you will
complete the correction.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s cost
for certain activities, including reinspection-related costs. A reinspection is one or more inspections
conducted subsequent to an inspection that identified noncompliance materially related to a food safety
requirement of the Act, specifically to determine whether compliance has been achieved. Reinspectionrelated costs means all expenses, including administrative expenses, incurred in connection with FDA’s
arranging, conducting, and evaluating the results of the reinspection and assessing and collecting
reinspection fees (21 U.S.C. § 379j31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for
reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this
letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA
may assess fees to cover any reinspection-related costs.
Please send your written reply to the Food and Drug Administration, Attention: Carla Norris, Compliance
Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any
issues in this letter, please contact Ms. Norris at (407) 475-4730.
Sincerely,
/S/
Emma R. Singleton
Director, Florida District
Page Last Updated: 05/20/2013
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Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters
Inspections, Compliance, Enforcement, and Criminal Investigations
Desert Rose Manufacturing 3/1/13
Public Health Service
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
Departm ent of Health and Hum an Services
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-2363000
FAX:
303-236-3100
March 01, 2013
Ref: DEN-13-9-WL
WARNING LETTER
VIA UPS OVERNIGHT MAIL
Gene S. (Sylvester) Eagle-Oden, Co-Owner/President
Gene S. (Susan) Eagle-Oden, Co-Owner/Vice President
Desert Rose Manufacturing, Inc.
1810 Washington Street
Anthony, NM 88021
Dear Mr. & Mrs. Eagle-Oden:
On July 10-12, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary
supplement manufacturing facility located at 1810 Washington Street, Anthony, New Mexico. Our
investigator found a number of violations of 21 CFR Part 111, Current Good Manufacturing Practice (CGMP)
in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. You can find the Act
and FDA regulations through links on FDA’s home page at http://www.fda.gov1.
Adulterated Dietary Supplements
The inspection revealed that your nuphedrine, alfa PXP Plus, Lithium Orotate, zialipro and cleanseRX
products manufactured in your facility, are adulterated within the meaning of Section 402(g)(1) of the
Federal Food, Drug, and Cosmetic Act (the Act) in that these dietary supplements have been prepared,
packed, or held under conditions that do not meet current good manufacturing practice regulations for
dietary supplements. These observations were presented to you in an FDA-483 at the conclusion of our
inspection on July 12, 2012.
The inspection revealed the following violations:
1.
You failed to establish specifications as required by 21 CFR 111.70 as follows:
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A specification for any point, step, or stage in the manufacturing process where control is necessary
to ensure the quality of the dietary supplement and that the dietary supplement is packaged and
labeled as specified in the master manufacturing record [21 CFR 111.70(a)];
Component specifications for each component used in the manufacture of a dietary supplement to
include:
o Identity specifications [21 CFR 111.70(b)(1)],
o Specifications to ensure the purity, strength and composition of the dietary supplements
manufactured using these components are met [21 CFR 111.70(b)(2)], and
o Specifications that establish the limits on those types of contamination that may adulterate or
may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the
dietary supplement [21 CFR 111.70(b)(3)];
In-process production specifications to include:
o Specifications for any point, step, or stage in the master manufacturing record where control is
necessary to help ensure that specifications are met for the identity, purity, strength, and
composition of the dietary supplements and as necessary, for limits on those types of contamination
that may adulterate or may lead to adulteration of the finished batch of the dietary supplement [21
CFR 111.70(c)(1)],
o Adequate documentation of your basis for why meeting the in-process specifications, in
combination with meeting component specifications, will help ensure that the specifications are met
for the identity, purity, strength, and composition of the dietary supplements and for limits on those
types of contamination that may adulterate or may lead to adulteration of the finished batch of the
dietary supplement [21 CFR 111.70(c)(2)], and
o Review and approval of the documentation required under 21 CFR 111.70(c)(2) by quality control
personnel [21 CFR 111.70(c)(3)];
Product specifications for each dietary supplement that you manufacture for the identity, purity
strength, and composition of the finished batch of the dietary supplement, and for limits on those
types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of
the dietary supplement to ensure the quality of the dietary supplement [21 CFR 111.70(e)].
Specifically:
Your firm has no records of any specifications for the identity, purity, strength and composition of
your raw materials such as vitamins, minerals, and botanicals that you use in the manufacture of your
nuphedrine, alfa PXP Plus, Lithium Orotate, zialipro and cleanseRX products.
Your firm has no records of any specifications for potential contaminants or limits for potential
contaminants for nuphedrine, Lithium Orotate, cleanseRX II, and zialipro finished dietary supplements.
The finished product cleanseRX II contains 21 vitamins and minerals; however, you have not provided
records of any specifications for the identity, purity, strength, or composition of the raw material or
the finished product.
We note that this is also a repeat violation cited in two previous inspections, July 22-27, 2010, and
September 12-15, 2011. We have reviewed your response letter, dated July 30, 2012, and have determined
your response to be inadequate. You state that you are currently in the process of reviewing specifications
for raw materials, in-process blends, bulk material, and finished goods as you work to define appropriate
testing methods for each specification. You also state that you will complete updating your MMR once
specifications and testing methods have been defined for each stage of production. You provided no
documentation of any product specifications to ensure the quality of your dietary supplements ((21 CFR
111.70(a)).
2. You must first establish component, in-process, and finished product specifications, which you have
failed to do, in order to comply with the requirements in 21 CFR 111.75 to ensure that your established
specifications are met. Specifically:
You failed to conduct at least one appropriate test or examination to verify the identity of a dietary
ingredient, prior to its use as required by 21 CFR 111. 75(a)(1)(i). We note that you must first
establish an identity specification for each component, as required by 21 CFR 111.70(b), so that you
can verify that such specification is met. Identity testing (ID) in-house is not conducted due to
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laboratory equipment failure. Even though you have purchased new equipment, a (B)(4), it is not
operational due to issues relating to the (B)(4). Furthermore, your firm did not send the raw materials
to an outside laboratory for identity testing when your equipment failed. The lack of testing affects all
(B)(4) lots of finished products manufactured in the past year.
You failed to confirm the identity of other components and determine whether other applicable
specifications were met by either conducting appropriate tests or examinations or relying on a
certification of analysis, as required by 21 CFR 111.75(a)(2).
o Specifically, even though your firm receives a supplier’s certificate of analysis, your firm has not
established specifications that the supplier must meet nor qualified your supplier, as required by
111.70(b) and 111.75(a)(2)(ii). You have not established the reliability of the supplier's certificate of
analysis through confirmation of the results of the supplier 's test or examinations, as required by 21
CFR 111. 75(a)(2)(ii)(A).
o
Raw materials that are received at your facility do not undergo any testing or confirmation to
ensure the materials meet your specifications and to confirm the reliability of the material received
against the Certificate of Analysis (COA).
Your firm releases raw materials for use in manufacturing based on the Certificate of Analysis (COA)
even though there are no established specifications that the COA is to meet, and the COA does not
include a description of the test methods used, limits of the test, and signature and date from the
vendor as required by 21 CFR 111.75(a)(2)(ii)(B).
o Specifically, we reviewed the COA of zialipro (lot 20441); two of the raw materials selected for
review failed to include required information. The third ingredient Red Panax Ginseng's COAs provided
did not match the lot numbers used in the Batch Record.
You failed to verify that your finished batch of the dietary supplement meets product specifications
for identity, purity, strength, composition and for limits on those types of contamination that may
adulterate or that may lead to adulteration of the finished batch of the dietary supplement for a
subset of finished dietary supplement batches that you identify through a sound statistical sampling
plan (or for every finished batch) as required by 21 CFR 111.75(c).
o Specifically, you have not established finished product specifications, as required by 21 CFR
111.70(e), nor conducted any testing to demonstrate that your products, nuphedrine, alfa PXP Plus,
Lithium Orotate, zialipro, and cleanse RX meet finished product specifications, as required by 21 CFR
111.75(c).
We note that this is also a repeat violation cited in two previous inspections, July 22-27, 2010, and
September 12-15, 2011.
We have reviewed your response letter, dated July 30, 2012, and have determined your response to be
inadequate. You state in your letter that your (B)(4) machine is now operational and you are in the
process of training new quality control staff in its use for testing identity of raw materials and
representative samples, and that you are also in the process of training quality control staff to conduct
other inspections and physical testing of materials at each stage of production to verify that materials meet
other established specifications. This response is inadequate because you provided no documentation of
any product specifications to ensure the quality of your dietary supplements ((21 CFR 111.70(a), nor any
documentation of testing, including qualification of your suppliers, as required by 21 CFR 111.75.
You also state that these inspections are currently conducted and documented by production staff and
that formal testing and release procedures will soon be implemented and documented by quality control
staff. However, you have not provided FDA with documentation of the completed inspections. Hence, FDA
could not determine the adequacy of these inspections.
3. Your quality control personnel failed to perform required operations to ensure that your manufacturing,
packaging, labeling, and holding operations ensure the quality of the dietary supplement, and that the
dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by
21 CFR 111.105. To ensure the “quality” of your dietary supplements, you must establish specifications for
the identity, purity, strength, and composition of your dietary supplements, among other requirements (see
21 CFR 111.3 for definition of “quality”). Therefore, in part, because you have no established specifications,
your quality control personnel also failed, for example, to approve or reject the processes and
specifications, as required by 21 CFR 111.105(a). For example, the quality control personnel must review
and approve the documentation setting forth the basis for why determining compliance with selected
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finished product specifications for testing or examination under 21 CFR 111. 75(c)(1) will ensure that the
finished batch of dietary supplement meets product specifications (21 CFR 111.105(d)). In addition, to the
extent you exempt one or more product specifications from the verification requirements in 111.75(c)(1),
you must document why, for example, any component and in-process testing, examination, or monitoring,
or other methods will ensure that such exempted product specifications is met without verification through
periodic testing of the finished product (see 21 CFR 111.75(d)(1)), and the quality control personnel must
review and approve the basis you set forth, as required by 21 CFR 111.105(e).
Specifically, nuphedrine, Bromelain with papain, alfa PXP Plus, Lithium Orotate, and zialipro, as well as all
(B)(4) lots of finished dietary supplements manufactured by your firm, have no documentation regarding
what the finished product specifications are (see § 111.70(e)), nor what finished product specifications you
use to verify that your finished batch of dietary supplement meets product specifications (see
§ 111.75(c)). This information is necessary so that the quality control personnel can review and approve
the documentation you use to verify that your finished batch meets product specifications for the identity,
purity, strength, composition, and limits on contamination, as required by 21 CFR 111.105(d) and (e), and
can approve or reject processes, specifications, written procedures, and controls, for example, that may
affect the identity, purity, strength or composition of your dietary supplements, as required by 111.105(a).
We note that this is also a repeat violation cited in two previous inspections, July 22-27, 2010, and
September 12-15, 2011.
We have reviewed your response letter, dated July 30, 2012, and have determined your response to be
inadequate. You state in your letter that your quality control staff currently reviews all batch record
documentation, including in-process, bulk pill, and finished goods worksheets, and that they will be trained
to review testing results and to document disposition decisions based on those results once testing
methods have been defined. This response is inadequate because you provided no documentation of any
product specifications to ensure the quality of your dietary supplements (21 CFR 111.70(a)), finished
product specifications (see 21 CFR 111.70(e)), or what finished product testing you do to verify that your
finished batch of dietary supplement meets product specifications for identity, purity, strength,
composition, and for limits on those types of contaminants that may adulterate or lead to adulteration of
the finished batch (21 CFR 111.75(c)).
You also state that your batch record has been updated to document the quality control release decision
for raw materials and components, in- process blends bulk pills, finished products, and any corrective
actions initiated. However, you have not provided FDA with documentation of any product specifications to
ensure the quality of your dietary supplement, nor updated batch records and records of related quality
control operations. Hence, FDA could not determine the adequacy of the quality control procedures.
4. Your firm’s batch production records (BPRs) did not include complete information relating to the
production and control of each batch of your dietary supplement products as required by 21 CFR 111.260.
Specifically:
The batch production records for the following dietary supplements were incomplete: nuphedrine (lot
#00807); Bromelain with papain (lots #10818, #00166, and #00660); alfa PXP Plus (lot #10501);
Lithium Orotate (lots #10707and #10312); and zialipro (lots #10716 and #10717). These BPRs were
missing the following:
o The results of any testing or examination performed during the batch production, or crossreference to such results, as required by 21 CFR 111.260(h).
o Documentation that finished product met specifications established in accordance with §
111.70(e) and (g), as required by 21 CFR 111.260(i).
o Documentation at the time of performance of any required material review and disposition decision
as required by 21 CFR 111.260(m).
We note that this is also a repeat violation cited in two previous inspections, July 22-27, 2010, and
September 12-15, 2011.
We have reviewed your response letter, dated July 30, 2012, and have determined your response to be
inadequate. You provided no product specifications to ensure the quality of your dietary supplement, on
which the testing or examination results of the finished batch are based, or missing documentation
(identified above) for the batch production record for each of the dietary supplements identified. You state
in your letter that you currently document all cleaning and control logs for equipment with reference to
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batch numbers for products made that day, and that your quality control staff approves the use of rooms
and equipment before product is made. However, you have not provided FDA with the documentation of
your cleaning and control logs for equipment with reference to batch numbers for products made that day.
Hence, FDA could not determine the adequacy of the quality control procedures for cleaning and for control
logs for equipment.
Your letter also states that calibration records for routine maintenance are kept and reviewed by quality
control/document control. However, you have not provided FDA with the documentation of the calibration
records. Hence, FDA could not determine the adequacy of the calibrations.
5. You failed to collect representative samples of a subset of finished batches of dietary supplements that
you manufactured before releasing for distribution to verify that the finished batch of dietary supplement
meets established product specifications as required by 21 CFR 111.80(c). Specifically, you failed to
establish finished product specifications (21 CFR 111.70(e)) and did not collect the required samples before
distribution to verify that the finished batches of (B)(4) lots/batches of nuphedrine, alfa PXP Plus, Lithium
Orotate, zialipro, and/or cleanseRX met product specifications established under § 111.70(e), and as
applicable, § 111.70(a). We note that, as required by 21 CFR 111.123(b)(2), the quality control personnel
must not approve and release for distribution any batch of dietary supplement that does not meet all
product specifications established under § 111.70(e). We also note that the failure to collect representative
samples for finished product testing is a repeat violation cited in two previous inspections, July 22-27,
2010, and September 12-15, 2011.
We have reviewed your response letter, dated July 30, 2012, and have determined your response to be
inadequate. You state that you redesigned your batch record to include documentation of sample collection
and in-process blends for finished goods, and redesigned your batch record to include documentation of
testing and testing results. However, you have not provided FDA with your revised batch records or
product specifications. Therefore FDA could not evaluate whether your revised batch records for these
dietary supplements address the failure to collect representative samples, as described in the citation
above.
6. Your firm does not use effective measures to protect against the inclusion of metal or other foreign
material in dietary supplements as required by 21 CFR 111.365(i). Specifically, there is no method used by
your firm to ensure metal fragments have not been introduced into the product after the use of tablet
presses and mechanical encapsulation equipment where metal contamination is reasonably likely to occur.
We have reviewed your response letter, dated July 30, 2012, and have determined your response to be
inadequate. You state that you "have re-purposed and conducted initial testing trials on our (B)(4) metal
detector". You also state that this is a very strong magnet and you have shown that bulk pills will be held
to the surface of the magnet when passed over it if the pill contains any metal contaminants. However, you
have not provided FDA with any documentation of these tests. Hence, FDA could not determine the
sufficiency of these initial testing trials.
7. Your firm did not have all the records required or copies of such records readily available during the
retention period for inspection and copying by FDA as required by 21 CFR 111.605(a) and (b). Your firm
does not have written procedures for operations as required by 21 CFR Part 111. For example:
No established in-house specifications for raw materials, in-process materials, or finished products for
identity, purity, strength, or composition, as required under 21 CFR 111.95(a) and (b).
No written procedures for holding and distribution, as required under 21 CFR 111.475(b).
No written vendor qualification program, as required under 21 CFR 111.95(b)(2).
No written release criteria for finished goods and no documentation of quality review before
distribution, as required under 21 CFR 111.95(b)(4) and 111.110(c).
No maintenance records for equipment utilized in manufacturing, as required under 21 CFR 111.260(c).
We have reviewed your response letter, dated July 30, 2012, and have determined your response to be
inadequate. All your responses to the violations cited above lack documentation of your stated actions, or
do not contain a time line for implementation. For example, you state in your letter that updated SOPs will
be written once new procedures are implemented. This response is inadequate because you do not provide
a time line for implementation of the new procedures.
We include the following comments:
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Your firm includes a shelf life on the labels for your dietary supplement products, including, but not limited
to, Yohimbe Extract, Calcium 0-Pantothenate, and Red Panax Ginseng Powder products. Any shelf life you
place on a product label should be supported by data that demonstrate the product’s shelf life [See 72 Fed.
Reg. 34752, 34856 (Jun. 25, 2007)].
Your firm failed to keep paper towels and/or toilet tissue in the production area and the men’s toilet in the
production area did not flush. Due to the condition of the restrooms, the sink area, and the lack of hands
free faucets, contamination is reasonably likely to occur. See the applicable requirements in 21 CFR
111.15(h).
Misbranded Dietary Supplements:
Your zialipro, alfa PXP Plus, and cleanseRX products are misbranded within the meaning of section 403(q)(5)
(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutrition information on the
labeling of your product does not comply with 21 CFR 101.36. Your cleanseRX and alfa PXP Plus labels fail to
present nutrition information in the form of a supplement facts panel.
Your alpha PXP Plus product is misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343
(s)(2)(B)] because it does not include a statement of identity as a “dietary supplement” as required by 21
CFR 101.3(g).
Your zialipro product label is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. §
343(s)(2)(C)] and in accordance with 21 CFR 101.4(h). For example, you do not list the name of the part of
the plant in English from which the dietary ingredient is derived for Tribulus Terrestris, Epimedium Sagittum,
Yohimbe extract, and Muira Pauma.
Your cleanseRX product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. §
343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as
required by 21 CFR 101.105
Your alfa PXP Plus product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §
343(f)] because the product label contains information in two languages, but does not repeat all the
required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any
representation in a foreign language or foreign characters, all words, statements, and other information
required by or under authority of the Act to appear on the label must appear in the foreign language.
This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to
ensure that your establishment and the products you market comply with the Act and its implementing
regulations.
Failure to promptly correct the violations specified above may result in enforcement action without further
notice. Enforcement action may include seizure of violative products and/or injunction against the
manufacturers and distributors of violative products.
Please advise this office in writing within 15 days from your receipt of this letter of the specific steps you
have taken to correct the violations noted above and to ensure that similar violations do not occur in the
future. Your response should include any documentation necessary to show that correction has been
achieved. If you cannot complete all corrections before you respond, state the reason for the delay and
the date by which you will complete the corrections.
Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance
Officer, at the above letterhead address. If you have any questions regarding any issue in this letter,
please contact Carolyn A. Pinney at (303) 236-3024.
Sincerely,
/S/
LaTonya M. Mitchell
Denver District Director
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