483
Cosette Pharmaceuticals NC Laboratories, LLCCosette Pharmaceuticals NC Laboratories, LLC – FDA 483, Jul 21, 2023
Record Details
An FDA inspection of Cosette Pharmaceuticals NC Laboratories, LLC in Lincolnton, NC, revealed significant deficiencies in their receiving warehouse operations. Observations included inadequate separation of raw materials leading to potential cross-contamination and failure to follow written procedures for handling damaged components. These issues indicate a lack of control over material handling and storage, posing risks to drug product quality.
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ID · a201478d-51ec-44bc-ae66-df943b769f1a
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