FDA 483 - Cosette Pharmaceuticals NC Laboratories, LLC - July 21, 2023

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.