Denison Pharmaceuticals, LLC – FDA 483, Jul 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.
ID · e4e9d792-bf44-4b54-b508-f0b77e37af5c
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