483
Amneal Complex Products Research LLCAmneal Complex Products Research LLC – FDA 483, Apr 18, 2018
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.
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ID · 275cbd5c-4c66-4ecc-86d3-ceba55388f0b
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