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483
•PEL Healthcare LLC•April 24, 2018

FDA 483 - PEL Healthcare LLC - April 24, 2018

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Record Details

G&W PA Laboratories, LLC, a human drug manufacturer in Sellersville, PA, was cited for failing to thoroughly review unexplained discrepancies and out-of-specification results. The inspection revealed multiple instances of incomplete investigations into product impurities and stability issues. This indicates significant deficiencies in the firm's quality control and investigation processes.

Company
PEL Healthcare LLC
Inspection Date
April 24, 2018
Product Type
Drugs
Office
Philadelphia District Office
Person
  • Anita R. Michael (Investigator)
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ID · 3d458a71-6c08-4fad-8377-38ed94068d16

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