FDAnews Form 483s Sample List Bio-Pharm, Inc. Neurovision Medical Products, Inc.

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FDAnews Form 483s Sample List
Bio-Pharm, Inc.
Issued: 11/21/12
Region: Central
Category: Drug 483s
Inspector(s): Anita R. Michael
Observations: Buildings used in the manufacturing, processing and packing of a drug
product are not maintained in a good state of repair.
Neurovision Medical Products, Inc.
Issued: 11/20/12
Region: Pacific
Category: Device 483s
Inspector(s): Sarah A. Hassass
Observations: Procedures for rework of nonconforming product have not been adequately
established.
Cardinal Health 414, LLC
Issued: 11/19/12
Region: Southwest
Category: Drug 483s
Inspector(s): Erika V. Butler
Observations: You did not notify all facilities that received a PET drug product that failed to
meet a criterion for sterility of the findings from your investigation.
Stryker Instruments Div. of Stryker Corp.
Issued: 11/9/12
Region: Central
Category: Device 483s
Inspector(s): Benjamin J. Dastoli, Allison M. Scheck
Observations: A correction or removal, conducted to reduce a risk to health posed by a
device, was not reported in writing to FDA.
Fredrikson Verkstad AB
Issued: 10/12/12
Region: HQ
Category: Device 483s
Inspector(s): Thai Duong
Observations: Procedures for device history records have not been adequately established.
AllerQuest, LLC
Issued: 5/18/12
Region: Northeast
Category: Drug 483s
Inspector(s): Ramon E. Martinez, Robert J. Martin, Allison A. Aldridge
Observations: There is a failure to thoroughly review any unexplained discrepancy and the
failure of a batch or any of its components to meet any of its specifications whether or not
the batch has been already distributed.
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