Amneal Complex Products Research LLCApril 18, 2018

FDA 483 - Amneal Complex Products Research LLC - April 18, 2018

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Record Details

An FDA inspection of Kasiya Pharma, LLC in Bridgewater, NJ, revealed two significant issues. The firm failed to thoroughly review out-of-specification (OOS) investigations, specifically regarding unknown peaks in samples, and lacked written procedures for its quality control unit's responsibilities, including AQL inspections.

Company: Amneal Complex Products Research LLC
Inspection Date: April 18, 2018
Product Type: Drugs
Office: New Jersey District Office
Person: Nancy F. Scheraga (CSO)

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ID · 275cbd5c-4c66-4ecc-86d3-ceba55388f0b