FDA 483 - Denison Pharmaceuticals, LLC - July 29, 2024

An FDA inspection of Denison Pharmaceuticals, LLC in Lincoln, RI, a human drug manufacturer, revealed significant deficiencies in quality control, facility maintenance, and production processes. The firm failed to adequately investigate numerous discrepancies, including OOS/OOT results, mold, and microbial contamination, and exhibited poor control over GMP documents, materials, and labeling. Additionally, the facility showed issues with cleanliness, pest control, and equipment maintenance, indicating a systemic lack of adherence to cGMP regulations.