DEPARTMENT OF HEALTH AND HUMAN SERVICES 483

OISTRICT
DEPARTMENT OF HEALTil A~O HUMAN SF.RVICES FOOD AND DRl:G ADMtNtSTRA'rtON OAT(IS) Of .,S•ECTlOH
ADilftfSS "'-0 """he NtWDtll
06/13/2011
11630 'II. 80th Street
Lenexa, KS 66214
Fax: (91J) 752-2111
(913) 752-2100
Industry I nformation: www.fda.gov/oc/industry
-
07/0 8/20 11 "
rEI Iiut.oii(R
1911445
NAME AJO lllU: Of ~ 10 WHON IIEPORT ll>sut.O
TO :
Terence J . Walsh, Site Leader
"""' ­
STAU 'AllORUI
Novartis Consumer Health
10 40 1 Hwy 6
CITY, ~T• a . lP~ ,CIJVNT"'
TYPE~ •
Lincoln,
Drug Manufacturer
NE
68517 - 9626
•
INSPECT< I>
This document lists observations made by the FDA rcprescntattve(s) during the mspcction of your f:tclluy. They arc inspcctional
observations, :tnd do not represent a final Agency dctermin:llio n regarding your compliance. Ir you have an objection regarding an
observatiOn, or have tmplemcntcd, or plan to tmplemcnt, corrective :~ction in rc~ponsc to an observatio n, you may discuss the objection or
IICIIOn with the FDA representativc(s) during the inspection or submit this information to r DA at the address above. If you have any
qucsttons, please eontuct flDA at the phone number and address above.
DURING AN INSPECTION OF YOU R FIRM WE OBSERVED:
OBSERVATION 1
The responstbtlities and procedures applicable to the quality control unit are not fully followed.
Specifically,
Your Quality Unit has fa iled in the responsibility and authority to monitor Quality Systems designed to
assure the quality of drug products manufactured and packaged at your firm . This failure is evidenced in
the Observations below (2-l3), as well as continued NDA Field Alerts and recalls for similar problems
over the last several years.
OBSERVATION 2
Written records arc not a lways made of investigations into unexplained discrepancies and the failure of a batch or any of its
components to meet specifications.
Specifically,
You have fail ed to open deviation investigations into numerous "critical" consumer complaints of I
foreign products found inside the drug products manufactured at your firm.
Specifically,
I
In the year 20 I0, you had 26 complaints where solid dosage form products (with confirmed mix-up
complaints of Novartis Consumer Health "NCH"-Lincoln manufactured product) were returned to your
EMPI.0Yff(SI $1CNAlUI\f
SEE REVERSE
OF THIS PAGE
•OIIM t OA ~IU (0'1101)
~
Investigato~~
Eric M. Mue lle r , I nv estigator
Joseph R. Lambert ,
,leVIOU1 fD ITIUN OIJSOlETr
INSPF.CTIONAL OllSF:RVA'r tONS
""''"~""':>
07/0 8/ 2011
P,\(j£ I 01' H
~AGIJS
DEPARTMENT OF IIEALTH Al~O HUMAN SERVICES
f OOD AND DRUG ADMINISTRATION
C>STRICT AOOftUS AN() P><Oit ..UMOER
06/1 3 /20 1 1 - 07 /0 8 / 20 11 *
1163 0 w. BO t h S treet
Lenexa . KS 66214
(913) 752 - 2100 Fa x : (91 3 ) 7 5 2-2111
I n dustry Informat ion : www.Eda .gov/ oc/ i nd us t rv
__
D.\T£l S ) ~IH$KCTIOH
... ........." 1 91144 5
""""'NfO l ll\.f 0' ltOVO\IA4 TO MOl RUORT IIS:s<.ti>
,TO :
Tere nce J. Wa lsh, Si te Leader
Novar tis Cons ume r Heal t h
C.TY. $ TA• t ~C()O(. COIIHIIW
Li ncoln , NE
6 85 17 - 9 62 6
- S1REE' AOORl SS
1 04 01 Hwy_ 6
T'fPE ESTA IUSHAENT 1HSI'tC1 ED
Drug Manufacturer
site, by a customer, and no official investigation was opened.
In the year 2009. you had 13 complaints where solid dosage form products (with confirmed mix-up
complaints ofNCI {- Lincoln manufactured product) were returned, by a customer, to your site and no
offici al investigation was opened.
This is important because a total of 40 confirmed returned consumer complaint samples (containing
mix-ups of NCI-1-Lincoln manufactured solid oral dosage form products) have not been adequately
investigated by your firm .
Additionally,
You have failed to adequately investigate 166 complaint instances offoreign tablets in your drug
products since 2009.
These instances refer to examples where the suspected sol id dosage oral products were not returned by
the complainant to the firm and no follow up was conducted by your Quality Unit.
Lastly,
Your Quality Unit's neglect to fo llow up with the complaint is a failu re to follow Procedure SOP­
202891, Conducting Deviation Investigations.
OBSERVATION 3
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug
products that may have been associated with the specific failure or discrep:mcy.
Specifically,
You have failed to extend investigations to aU batches of product potentially affected by a
problem.
For example,
1 5oC.,~T\.R£
SEE REVERSE
OF THIS PAGE
tt()lt~l ~II •\
<IJ lOMlJ)
OA1 E ls.suEO
Eric M. Muell e r , I n vest i gator
Joseph R. Lambert, Investigator~
rUVIOUS f.IJI TIOM OIISOLET!
~
INS Pf.CTIONAI. OOSf.RV ATI()N S
07/0 8 / 2 011
D£P,\ RTMENT OF HEALTH AND HUM AN SERVICES
FOOD AND DRUG ADMINISTRATION
Olli1R1CT AOOflfU • hO~ N\NOER
OAT[(SIOT..SPlCTiOfl
116 30 w. 80th Street
Lenexa , KS 6621 4
( 913 1 752-2 100 Fax: (913 ) 752-2 1 11
Ind ustry I n f o rmation: www.fd a.gov/oc/ industry
06/ 13 / 2 0 11 - 07 / 08 / 2011 *
1 911 44 5
NAME""" llU Of HlMDUAL TOWitOM REPORT ISSIIEO
·-­
TO :
Te r e nce J . Wa l sh , S t te Leader
$1RUT AOOM$ll
Novart i s Consume r He alth
10401 Hwy 6
CITY, STATE Zll' QJDf , toUf<TRY
TYPE E$1AIU$i<I.OENT lilsPfCTEO
Li nc ol n , NB
Drug r1anufac turer
68 51 7 - 9626
A) Your Qual ity Unit failed to extend the investigation to all lots/batches of product potentially affected
for a recent mix-up complaint of Excedri n Migraine Tablets, Lot # 10087498, mixed with Excedrin
Migraine Caplets. This complaint is associated with NDA Field Alert, dated 10/1 5110.
Lastly, the conclusion of th is investigation, reads in part, "it is not possible that the products were mixed
within Novartis control." does not appear to be supported by the evidence in your investigation. The
two products in the complai nt sample were actually packaged on the same equ ipment within 4 orders of
each other. Also, the investigation revealed several areas in the process where the two products could
have possibly come into contact (compression, fil m coating•.transport, packaging).
B) Your investigation of Unp lanned Deviation PR, No: 8851 0, (opened March 2, 2011) investigating
complaint I 0656633 of mixed Ex.cedrin Extra Strength caplets, Lot: l 0099302 with Excedrin ES
Gelcaps did not extend to all lots/batches of product potentially affected. In this instance, the two
products were packaged on the same lind>(4) consecutively.
These are just two examples of numerous instances in whicb your firm's deviation investigations
do not extend to other lots/batches of product potentially affected by the problem.
THIS IS A REPEAT DEFIC IENCY FROM THE PREVIOUS INSPECTION AT YOUR SITE,
DATE D 4/5-16/ 10.
OBSERVATION 4
An 1'\0A-field A le n Report was not submilted within three working days of rece ipt o f in formation concerning an inc1dent
thai caused o dn1g prod uct o r its labeling to be mislaken for ano1hcr nn ick.
Specifically,
You have fail ed to fil e NDA Field Alerts within 3 days of a problem being identified .
You have received numerous consumer complaints which were not submitted to the FDA as
r equired by your firm' s procedures:
( MPI.On£1S ) ~NATIR
SEE REVERSE
OF THIS PAGE
Eric M. Mu e l le r , I nvestigato r
.
~
J o seph R . La mbert , I nve s t i gato r~ 41~
rou:voous EDiliON OllSOU11!
INSP ECTIONAl. O DS•: Itv/\TI ONS
07 / 08/ 2 011
PAGE J OF Il l'AGES
DEPARTMENT OF II EALT H ANO II UM AN SE itv i CES FOOD AND ORIJG A0.'-11NISTRATION l!.lf£1SIOFlloiSPEC1 ~
-OiSffOICf AOCAUSNCI't<()!.E HUMif.ll
11630 W. 80th Street Lenexa, KS 66214 ( 913) 752 - 210 0 Fax : ( 913) 752-2111
I ndustry Informa t i on: www.fda .gov/oc/i ndustry -
NoO
06/13/2011 - 07/0 8 / 2011*
1911445 l lllfOI ..o<IIOIJ.U.IOWH()N RU'OIITIS5Uf0­
T0 :
Terence J. Walsh, Sit e Leader
fiRI.I­
SIIIEET ADORES$
Novartis Consumer Health
10401 Hwy 6
erN SIAIE. ZIP eoot. COUNTIIY
IT"'l$1- HT. . . -c;KO
Li ncoln, NE
Drug Manufacturer
68517-9626
For example:
A) Since October of20 I0 (a period in time where second person review of consumer complaints ceased
at your finn), there have been 21 consumer complaints (for NDA products) that procedurally should
have been reported as 3 day Field Alerts. A review of two individual Technical Complaint Investigation
Reports fo r two of these NDA mix-up complaints (case 10642591 and case I 0675854) revealed your
investigation and conclusion Uusti fication) for not subm itting 3 day Field Alerts was inadequate. Also,
these two rep orts are indicative of a p attern of problem at your firm.
It should be noted that this number was only verified beginning from October 20 10, but is indicative of a
problem fo r all consumer complaints received by your fi m1 for mixed solid dosage fonn products on the
market.
B) You have failed to file a 3 day Field Alert as required by your procedure, for complaint 10650826
regarding a mix-up of Excedrin Migraine Caplets, received on 1/26/ ll. The complaint sample was
received by your fi nn on 2/14111 and confinned on 211611 I. However, your initial 3 day Field Alert
was not submitted until 2/22/1 1.
It shou ld also be noted the conclusions drawn into the investigation of this mix-up did not appear to be
supported by evidence gathered during the investigation. (See Observation 8-C)
C) You failed to fi le a 3 day Field Alert as required by your procedures, for complaint I 0642060
regardi ng a mix-up of Excedrin Migraine Geltabs (lot: I 0039449), received on 1/5/ l l . The comp laint
sample was received by your ft m1 on 2/ 111 I and confinned on 2/4/11 . However, your initia13 day Field
Alert was not submi tted until 2/8/ l l.
Add itionally, this complaint involves a mix-up of Excedrin Migr aine Celtabs, Lot : 10096621 ,
expir es: 7/ 12 a nd Exced rln Migr aine Tablets, Lot : 10039449, expires 7/10. The carton in qu es tion
(Exced rin Migra ine Celtabs, Lot: 1009662 1, expires: 7/12) was not r eported as r eq uired by your 3­
day Field Alert proced ures (all lots potentially affected in the complaint wer e not add r essed in th e
Field Alert, dated 218/11)
lMI'!.OVte{fniO"•Ao~
SEE REVERSE
OF THIS PAGE
FOit~ l mA •
1.1 CO..UN)
. , .•• 1$....0
Eric M. Mueller, I nvestigator
Joseph R. Lambert , Investigator~
INS P ECT IONAI. O RS F.RVAT IONS
~~07/08/2011
PAC.( ; OP CJ PACCS
o •: PARTM[NT OF IlEALT il A.~O HUMAN SERVIC£5
1'000 AND ORUO A D\11:-.II<:TRATION
Otli!~T ADClMSS ANOFHOHE
NIWI"'
OATE(S) UP '"" - .'"""'
11 6)0 w. 80th Street
Lenexa , KS 66 214
( 913) 752 - 2100
Fax : (913 ) 7 52 - 2111
Industry Informat ion: www.fda.gov /oc/ i ndus t ry
06 / 13 / 20 11 - 07/ 08/ 20 11 *
t e~ MNKK
1911445
NAMf ANO lilt 0/INOIVIOUAL TO WHCM M•I"'f<T IS SUED
TO:
Terence J. Wa l sh , Site Leader
~el f AOOI\tSS
• ootMNAMC
S
Novartis Con sumer Heal th
104 01 Hwy 6
CITY STATE lP CODE. COUNTRY
Tl?lt STA~NTINSPECTEO
Li ncoln , NE
Dr ug Manu factu rer
6 8 517- 9626
A further review of your firm's complaint file revealed Excedrin Migraine Tablets, Lot: l 0039449 (same
lot as above) had a second mix-up complaint on 4/2/08 that appeared to have an unsupported conclusion.
Your firm's procedure, SOP-202335, OTC NDA Field Alert Reports, dated 7/31 /09, reads in part,
"Reports must be submitted to district FDA offices within three (3) days o f a problem bei ng identified.
The three (3) day timing starts when the firm becomes aware of a reported problem (ie. complaints or
intemal testing)."
OBSERVATION 5
The batch records do not record the distinctive identification number, code, and name of equtpmentto identify major
equipment to show the specific equipment used in the manufacture of a batch of a drug product.
Speci fically,
You have failed to document the distinctive identification of the slats utilized on the IUlBDtablet fillers
during packaging operations on non-dedicated packaging LinesDIU andllil (Lineilaand­
are used to package products such as Excedrin tablets, caplets, gel tablets, Bufferin, and No doz) (Line
is used to package DEA schedule products such as.auJWI and •mmwsolid dosage forms)
n
This is important because the dedicated slats are utilized as supporting evidence in two of your
complaint investigations. These investigations (identified as Unplanned Deviation Report 74956 and
73243) state in part:
"...The cavities in the slats are dedicated to a specific size product dose. The cavities in the slats
used fo r Excedrin caplets are too small to hold Excedrin tablets. If Excedrin tablets had been in
with the bulk caplets, they would have remained in the hopper. The packaging equipment used
does not support this complaint."
This conclusion is based on knowing which dedicated slat was used in production (there are lllldi fferent
sets o f dedicated slats which can be utilized in packaging Lineslll &U. However, there was no
documentation in the batch record of the dedicated slat used to package batch records I 0074660 and
I 0066070, which are associated with Deviation Reports 74956 and 73243, respectively.
Furthermore,
. ............ (>! ""'"" IJRE SEE REVERSE
OF THIS PAGE
WMM t'I}A dJ tOWOI)
OA1t 1UUW
Eric M. Muel l er , Investigator
J os e ph R. Lambe rt, I nvestigat o ~
f'Ml)Vt()C~ EOtt i ON Q IJSOl.E rl~
INSPECTIONAL ORSF.RVA TJONS
~ ~7/08/2011
PAGii HIP ll PMiES
UCPA RT MtNT Of 11£Al.TH AND HUMAN SERVI Cf.S
f OOD AND DRUG AO!Io!INISTRATION
I
05TRICT •DO R~SS ANO PHONE NVM~R
I
DA.TEIS)OF INSPECTION
11 630 w. 80th Street
Le nexa . KS 66214
(9 13) 752 ­ 2100 Fax: (913} 752 ­ 2111
I ndustry I nformation: www . fda .gov / oc/industry
06/1 3 / 2011 - 0 7/ 08 / 2011 *
Ft1 HUM8ER
1911445
NAME ANC TITlE OF INONI<>UAL TO WHOM Rtt"VP<T ISSUED
Te rence J. Wal s h, Site Leader
TO:
Flii.MNA""
S IAEETAOORESS
Novartis Consumer Health
10401 Hwy 6
Pt t .. ABU>>tMt:NI l~l'l:<.; t tO
CiTY. STATE. ZIP~. COONtRY
Lincol n. NE
6 8517-9626
Drug Manufacturer
From 1/ 1/09 to 6/26/ 11, there have been
U*bottles packaged on Linelllli,MiiJIUWibottles
tiJDJ*bottles packaged on LineB According to a Novartis Quality
packaged on Line[U and
Manager, none of these bottles have documented traceability to a particular set of slats.
OBSERVATION 6
Deviations from written production and process control procedures are not recorded and justified.
Specifically,
Your Quality Assurance review of critical foreign tablet complaint investigations (Technical
Complaint Investigation Reports) is not occurring in a timely manner.
A review of foreign tablet complaint investigations, received by your firm, since 1/ 1/2009, revealed a
total of 367 of 401 critical Technical Complaint Investigation Reports, have not been second-person
reviewed within liCDalendar days as required by your procedures.
Th er e are approximately 138 reports that took over 100 days to review.
According to your procedures, closure (including QA review) of individual complaint investigations
should be completed within !Didays of receipt for all critical complaints (pe r Complai nt Handling
Procedure, SOP-2023 13).
OBSERVATION 7
Written records of investigation of a drug complaint do not include the findings of the invcsligation and the foll ow-up.
Specifically,
You have fail ed to identify the root cause of customer complaints for solid dosage form forei gn
tablets of products manufactured at your firm since at least 2009.
EMPI.O'tt:E(SI SICNATIJRL
SEE REVERSE
OF THIS PAGE
fOII~I
fO,\ <11.1 (0..0¥)
OA<E ISSIJEO
Eric M. Mu e lle r , Investigator
Joseph R. Lambe r t, I nvestigator4"-'
l'KEVI()U$ tiDiltON 01\.WUit.
INSPECTIONAL OUSERVATI ONS
I() ~ /08/ 2 011
PAGF. 6 OF tJ PAGI!S
ll£PART:0.1 E~T O F IlEA LTH ,\ NO HUMAN S ERV IC ES
FOOD AND ORUO AOMINISTRA riON
,...., .....,
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• ..., • ...,... HI)......
06/1 3 / 2 0 1 1 . 0 7/ 08 / 201 1 *
11630 W. 8 0 th St reet
Le nexa , KS 66 214
(913 } 752 · 21 00 Fax : (913 } 7 52 · 21 11
Industry I n f ormat ion: www.fda .gov/ oc / indust ry
__
Mlolf lftJ ITU or' " ""10JAI.
,TO :
JU WHOM
IW'ORT ISSU£0
Te r ence J . Wals h , S i te Leader
Nova r t is consume r Heal th
errv s TAn .v
CXXlE
couoron
Linc o l n , NE
10 40 1 Hwy 6
TYP£ t S1-
685 17 - 96 2 6
HT ...sl'tCt£0
Dr u g Manufac turer
Since 2009, you have received approximately 57 returned customer complaint, mix -up samples
containing only NCH-Lincoln produced product.
Despite the continued evidence of solid dosage form mix-ups over these years, you have not determined
a root cause of tablet/capsule/geltabs mix-ups.
As an examp le of the above,
A) You have fa iled to justify the root cause for a recent mix-up complain t of Excedrin Migraine Tablets,
Lot# 10087498, mixed wi th Exced rin Migraine caplets.
The direct cause was identified as "Occurred outside Novartis Lincoln Control", however, there is no
evidence to support your root cause. T his is just one example (showing a pattern) in which the root
cause of the mix-up was determined to occur outside Novartis Lincoln control with out
documented justification.
Lastly,
Your conclusion reads in part, "**based on this investigation, it is not possible that the products were
mixed within Novartis control."
However, a review of the investigation into this problem revealed Excedrin Migraine Caplets were
packaged on the same line Ill> four orders prior to Exccdri n Migraine Tablets, Lot: 10087498, and
immediately aller.
B) You have fa iled to j ustify the root cause determinati on for a recent mix -up compl ai nt ofExcedrin
Migraine Gel Tabs, Lot # I 0072553, mixed with Excedrin TH Express Gels.
You have concluded, "The only possible way that the Exccdrin TH Express ge l caplets to have ended up
inside the Excedrin Migraine GelTabs was for it to happen after the customer had opened the bottle.''
However, there is no documented evidence to support this root cause.
T HIS OBSERVATIO N DEMO NSTRATES A PATIER!'l OF PRO BLEMS AT YO UR FIRM.
(lo'PI.0 Yff l5) S""'ATIJRO
SEE REVERSE
OF THIS PAGE
8 r ic M. Mueller , I nv e stigat or
Jos ep h R. Lambert , Inve stig a tor ~
r o ~vtOllS EDITlOH OBSOLP.TE
INSPECfiONAL O BS F.K V1\T IONS
k:/~0
[&
07/08 / 20 11
MGF.1 OF IJ PAGI::>
O£PAIHMENT Of HEALTH AND HUMAN S ERVIC F.S FOOO AND DRUG ADMIJI:ISTRATION DATE(Sl OF INSPECTIOH
Ot5TIUCT •COI'us •..o oH6iieN\J"u"
11630 W. 80th Street
Lenexa, KS 66214
(913) 75 2 - 21 00 Fax: ( 913) 752 - 2111
Industry Information: www.fda.gov/oc/industry
-
06/13/2011 - 07/08/2011 *
1911445
ANO TITU! 01' INOIV-IDU..\L TOWHO>ol ~El'Of<T ISSUED
TO:
Terence J. Wal sh , Si te Leader
STREeT ACORtSS
-rillll.l NAUE
Novartis Consumer Health
10401 Hwy 6
Clr\';STATE, l:.P QOOt: , GOU>rTRY
l VPE ts AIII.ISHMEHT lN ~CT£0
Lincoln, NE
Drug Manufacturer
6 8517-9626
OBSERVATION 8
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
Specifically,
Your Unplanned Deviation Reports are deficient in th at conclusions drawn are not supported by
the evidence in the reports.
For example,
A) The conclusion for Unplanned Deviation PR, No: 83756 (opened 10/20/10 and approved 10/22/10
for foreign tablets inside of Prevacid 24 hour packages) is not supported by evidence documented in the
report.
The conclusion reads, in part, "Product pilfering is the most likely cause"""*Deliberate***Cause
Verified". Additionally, the summary reads in part, 11 it appears the package was pilfered outside of
Novartis' control. " It also states, in part "it appears the carton was resealed/reglued and returned to the
retailer for refund with Prevacid tablets being replaced with acetaminophen tablets. The suspect
package was subsequently placed back on the shelf and purchased by the noted complainant."
A review of your investigation revealed there was no evidence to support the root cause (above) and
conclusion that the sample was "pi lfered".
B) Your conclusion for Unplanned Deviation PR, No: 88510 (opened March 2, 20 11, investigates
complaint 10656633 of mixed Excedrin Extra Strength caplets, Lot: I0099302 with Excedrin ES
Gelcaps) is not supported by the information in the investigation.
Your conclusion reads in patt "Based on all the supporting evidence above, there is a very small to no
possibility that the foreign product was introduced through Novartis procedures and practices."
Further review of the information in the report indicated both products in the complaint (Excedrin Extra
Strength Caplets and Excedrin ES Gelcaps) were packaged by NCH-Lincoln on the same equipment
(linel!ill in the firm) consecutively, on the same day 10/4/10. This information does not support your
summary.
E...,LOYEEtS) S<C"A UI'!(­
SEE REVERSE
OF TH IS PAGE
EriC M. Mue ller, Investigator
Joseph R. Lambert, Investigatorqrf Kt'VIUtiS I:OITIUN OllSOUtl'll
INSPECTIONAL ODSF.RVATIONS
VU£D
4. 07/08/2011
PAGE H 0~ I)
PA<IbS
j
OF.PA RTM E~T O f Hf.ALTH A.' l l) II UMA I'I S f; KVICF.S
fOOD AND DRUG ADMINISTRATION
DAlllll 01' INSPtCliON
""''""'t-$SAHO- - M i l
11630 w. 80th Street
Lenexa , KS 66214
(9 13 ) 752-2100 Fax: (913) 752-2111
Industry Informat ion: www.fda.gov/oc/industry
HA.IoOI!
No()
TO:
flU< ()I'
06/13/2011 - 07/08 / 2011 *
f(II>IJMM"
191144 5
. ..,.,.......... 10 WMI,l. . M<f'U<l i":W~D Terence J. Walsh, Site Leader
fiRM I"""
Novart i s Consumer Health
10401 Hwy 6
C11 • ~tA tLZJ'COOt: COUinRY
I.....E UTAt0$>1Nti<T tml'llCTLD
Li n coln, NE
Drug Manufacturer
68517-9626
C) Your conclusion for Unplanned Deviation PR No: 878 17 (opened 2/ 16/ 11, investigates complaint
I 0650826 of mixed Excedrin Migraine caplets, Lot: I0 I 01757 with Exccdrin Migrai ne Tablets) is not
supported by the infonnation in your investigation.
Yo ur conclusion reads in part "This event occurred outside ofNovartis con trol.", also "The incident is
believed to have occurred outside of the manufacturing, packaging and holding operations at Novartis
based on this investigation it is not possible that the products were mixed within Novartis control."
There is no documented investigational evidence to support your statement "This event occurred outside
of Novarti s Control". The product in the returned sample was packaged at NCH-Lincoln on line wmll
within 3 days of each other ( ll / 17/l 0 and 11/20/1 0). Additionally, your investigation also revealed
several areas in the process flow where the product could have come into contact (compression, film
coating. Transport bins, packaging).
THE ABOVE EXAM PLES REPRESENT A PATTERN OF PROBL EM AT YOUR FIRM
WHERE INVESTIGATION CONCLUSIONS ARE MADE WITHOUT J USTI FCATION.
OBSERVATION 9
Wnllen procedures describing the handling ofcomplaints do not include provisions for review by the quality control umt of
any complamt involving the possible failure ofa drug product to meet any of its specifications, a determination as to the need
for an investigation of any unexplained discrepancy, nnd explaining the reasons for the failure of the batch or any of its
components to meet spcci lications.
Spcci fically ,
Your Quality Assurance Unit has consistently fail ed to review critical co mplaints for drug
products manufactured and packaged at your fa~i l ity.
For example,
20 11 : 223 cr itical co mpl aints have not been prop erly reviewed out of223 critical complaints r eceived by your firm. tW'lOY£[151
SEE REVERSE
OF THIS PAGE
$.,,.. UAt;
Eric M. Muel l er, Investigator
Joseph R. Lambe rt, Investigatorctl'ftR\< IOUS J1UI tiOto~ r)USOLI!TE
INSPECTIONAI. ()JIS.: IlV A 1· 10NS
()J:PA RTMf:t~T OF IlEALTil AND HUMAN SERV IO:S
FOOD AND ORI.!G ADMINI~i!IA rtON
-OATE(Slll' lhSl'ECTION
D<S'TRICT ADORIII ANO P><CIIl NU... EII
06/13/2011 -
11630 W. 80th Stre et
Lenexa. KS 66214
( 913) 752 - 2100 Fax: (913) 75 2-21 11
__
I ndus t ry Information:
07/08/2011 ~
1911445
w~~.fda.gov / oc /i ndustry
- ~A>Q hT\.IOII'CJMOUloi.TQ"'-MEPOAT ISSUED
,TO :
Terence J. Walsh , Site Leader
STIIfH...,.,..t:.S
104 01 Hwy 6
Novart1s Consumer Health
c:rrt. STATl ~ coo•t. COUM
Lincoln, NE
TY PE U T,.IUIIHMOf "'5PI!CIW
If
Drug Manufacturer
68517-9626
20 10: 165 critical complaints have not been properly reviewed out of 587 critical complaints received by your nrm. Also, your Qu ality Assu ran ee r eview of critical complaints ceased in mid-Octobe r of 20 I 0. This deficiency was unnot iced by your Quality Unit until this FDA inspection. Speclflc to For eign Product Complaints: Since October of20 I0, a total of 88 consecutive critical complaints of foreign tablet complaints have not
been adequately reviewed or investigated by your Quality Assurance Department.
In this instance, your Complaint Handling Procedure SOP-202313, a nd Q uality Manual, Module
N 14.3 were not followed.
OBSERVATION 10
Procedures describing the handling of written and oral complaints related to drug products are not written or followed. Specifically, A) Your Qu ality Directive 2.1.01, Ma nagement Escalution Process, is routinely not followed . For example, your site is procedurally obligated to report to Global QA "Any (critical) complaint or adverse event that may result in a potential 3 day Field Alert, BPDR, recall, correction or market
withdrawal or may require non-routine regulatory reporting.''
This procedure has not been followed, as Novartis corporate personnel was not aware (for a minimum o f
the last two years) of your critical complaints regardi ng complaint mix-ups until early June of2011.
0 ) You have fail ed to send postage-paid mailing ma teria ls to custome rs co mplaining of for eign
tablets (conside red "critical " by your firm) as r equired proced urally by SOP, 2031 33, version I,
d ated 1/22/ 10.
EMP\.O~tfS l SIGH.\TUIII!
SEE REVERSE
OF THIS PAGE
~Uit~t
I' OA •11.1 (O'NOi)
Eric M. Mu el ler, Inve stigator
,Joseph R. Lambert,
ftk EVJOtJ~
t'l>lflt)N ()U.WI.flt
Investigator~
INS I'ECTIONAI. OUS ERV ATIONS
vg
ft.
07/08/2011
PAt oM tU U~ tl 'AOI..S
Of.PARTMENTOF IlEALT N MID II U•\ fAN SI':RV In:s
FOOD AND DRUG ADMlNlSTRt\TlON
ciijlRICf AOOI\ESS ...0 P><()NE NUMBlR
OAlltS) 01 IHSPfCTIOff
06/13/2011 - 07/08/2011 •
1 1630 W. 80th Stree t
Lenexa, KS 66214
{913) 752-2100 Fax: (913) 752-2111
'1:1 ~11
1911445
Industry Information: www.fda.gov/oc/indust r y
HAM( AICl OllE 0# ~ TO\\>tOOI REPOAHiSUEO
TO :
Terence J. Walsh, Site Leader
SlliU ' ACOAEU
""""""'«
Novartis Consumer Health
'""l:il'i'SJA1f Z#COOE, CQ.i!o;fiiY
Lincoln, NE
68517-9626
10401 Hwy 6
rT!'f; t ~•
IM$KC1UI
Drug Manufacturer
In 20 II, a total of 5 instances occurred where postage-paid materials were no t sent to complaining
customers when deemed necessary.
In 20 l 0, a total of 13 instances occurred where postage-paid materials were not sent to comp laini ng
customers when deemed necessary.
This is significant, because neg lecting to ship the postage- paid materials to the complainant
expunges any attempt for the s uspect product to be returned and properly investigated by your
firm.
It is important to understand also that no person in Novartis was aware of this failure until the
information was requested by the FDA on 6/16111.
OTHER PROCEDURES CONSISTENTLY NOT FOLLOWED INCLUDE:
C) Complaint handling Procedure, SOP-202313, dated 5109, was not followed in that critical complaints
were not reviewed and investigations are not conducted as required .
D) Deviation Investigation Procedure, SOP-202891, dated 6110, was not fo llowed in that investigations
were not always opened as required, all lots/batches of product potentially affected were not detenn ined,
conclusions were not justified and root cause was routinel y not identified (regarding foreign tablet mix­
ups).
E) Quality Manual for Handling of Consumer Complaints, Module N 14.3, was not fo llowed in that
critical complaints were not reviewed or approved as required. Additionally, adequate corrective and
preventative actions were not add ressed and followed up (regard ing foreign tablet comp laints).
OBSERVATION 11
Tlle number of qualified personnel is inadequa1e 10 perform and supervise the m:~nufacturc, processing. packing, and holding
ofeach dmg product.
Speci fi ca lly,
l MI>t.OYE.ftSI SIGNA VAE
SEE REVERSE
OF THIS PAGE
D.\lf
Eric M. Mue ller, I nvestigator
Jos eph R. Lambert, I nvestigator q;­
I'll!!\.l OllS EDit'lON OlllOILTI'
INSPECTIONAL ODSE itvi\TIONS
ISSIJ~D
t;V_
07/08/2011
Pi\GI! II OF 1.1 M<Jl;$
-
llJ:PARTMF.NT OF HF.ALTII ANO II UMAN SEI~ VIO:.S
1'000 fiNO DRUIJ ADMINISTRATION
Olt~IOCT
•o· ..fSS AHO - NYMI!ER
DATf.CSJOf II<SI'ECTIOH
0 6/13/2011 - 07/08/2011 *
11 63 0 W. 80th Street
Lenex a, KS 66 21 4
(913) 7 52 - 2 100 Fax: (9 1 3) 752- 2 111
Indu stry Inf ormat ion : WW'N.fda.gov/oc/indus try
-
''-'""'_,
1911 44 5
ANO 111\.E Of I'<OMOUAI. TOYh1<lM MtPORT I$SIJ[ D
TO :
Terenc e J. Walsh, Sl te Lead er
STRUT AOOAU$
F\AM ­
NOVar t i S Consumer Heal th
CITY.
S1A~l11' COOf
Li nc oln, NE
104 01 Hwy 6
~
wur<TIIY
6 8517- 96 2 6
u iAkiS>tMtHT ..S~G TfO
Drug Manu facture r
T here are an inadequ ate number of personnel condu cting and reviewing (nt a minimum)
co mplaint investigations occurring at your firm.
This was evidenced in your fi rm's lack of review of critical complaints as required procedurall y.
This was also evidenced by the fact that once the defic iencies were discovered (du ring this FDA
inspection), you brought outside assistance to conduct the reviews which should have originally been
done by your Quali ty Assurance staff at NCH-Lincoln.
Also, you have one person (or designee in absence) conducting and closing initial complaint Technical
Com plaint Investigation Reports. This is inadequate as evidenced by fail ing to open*IDU*
investigations when needed, developing conclusions not supported by evidence, and consistently failing
to follow up complainants when necessary.
OBSERVATION 12
GMP training is not conducted with sufficient frequency to assure that employees remain fa mil i:~r with CGMP requirements
applicable to them.
Specifically,
Trainin g is inadequ ate in th e Quality Unit at your firm.
This is evidenced by the problems documented: failure to opcn EIQIIinvestigations when needed,
investigational concl usions not supported with evidence, fail ures to satisfy 3-day Field Alert
requirements, fa ilure to escalate critical complaints to corporate personnel, failure to notify top
management when Quality procedures are not being followed due to time constraints, and consistent
failures to follow up wi th complai nants when necessary.
Most importantly, a lack of training is evidenced by the fact that no person at NCH- Lincoln recognized
the fa ilures in the Quality Unit's Oversight (see Observations above) prior to this inspection.
(IM',Q"J1!C..:>)""""" IUJOf
SEE REVERSE
OF THIS PA GE
OAI E t:>SUEO
Er ic M. Mu e lle r, Investi gato r
Jose ph R. Lambert, I nv est i gator
..IIPV.Otli f!UITIIJNOI\SOI.tl'r E
~
INSPECT IONAL ODSERVATI ONS
a~OB/ 20 11
PAGE
I~
OF IJ PAGJ.S
0[ PARTM£NT O F HEAtT il Al"/0 HUMAN SERVICES
fOOD AND DRUG ADMINISTRATION
IOo$'1!tTIOH
OIST~U<;T AOOf!US """""""' ...,..._,.
OAT~SJOf
11630 w. 80 t h Street
Lenexa, KS 66214
( 9 13 ) 752 - 2 100 Fax : (913) 75 2 - 211 1
FEINUM8fH
06/13/2011
-
07/0 8 /20 1P
191144 5
Industry Information: www.fda.gov/oc/industry
kAN E AH0 TITLE Of IHOIVIOUAL TO V.HON REPQOIT ISSUEO
TO :
Terence J. Walsh, Site Leader
STREU AOORUS
FIRIAHAIIE
Novartis Consumer Health
10 4 01 Hwy 6
CITY. ST4 TE. l "' COCE.COuHTIIY
lYI'I!
Li ncoln, NE
Drug Manufacturer
68517 -9 626
f.HT "'SI'ECT£0
OBSERVATION 13
W r itten records of major equipmen t c leaning, mai ntenance, and use are not included in individual equtpment logs .
Specifica ll y,
Your Use Sequence Log, used to document packaging activity on non-dedicated equipment (line •
not always completed by your operators assigned to verify packaging line clearance.
• is
There is no operator signature in the Use Sequence Log for "Dates of Major (wet) clean o nly" indicating
major cleans are conducted as required after a particular packaging run. Major cleans should have been
documented on the forms after: Excedrin ES Tablets (6/10/09), Excedrin AFTH (6/11/09), Excedrin PM
Capsules (6/ 18/09) however, this was not completed.
T he exa mple above is indicative of how your firm currently operates with r cgord to fili ng out line
usage logs for a ll packaging lines.
*DATES OF INSPECT ION:
06/1312011(Mon}, 06/14/2011(Tuc), 06/15/20 II (Wed}, 061171201 1(Fri), 06/20120 11(Mon), 06/2112011(Tuc), 061221201 1(Wed).
06/23/20 I I(Thu), 06/27/20 II (Mon), 06129120II (Wed), 07/01/20 II (r:"ri), 07/08/20 11(Fri)
/
....W,ffiSI-AT.....o
SEE REVERSE
OF TH IS PAGE
f ORM rD,\
~I.I IMIUI)
Eric M. Muel l er, Investigator
Joseph R. Lambert, Investigator
~
·cr 45
, . £\llOOS UlmOf< ~n:
INS PECTIONAI. OBS F.RVATIONS
O..l£ 1$$•• 0
07/08/2011
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