PEL Healthcare LLCApril 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