FDA 483 - Denison Pharmaceuticals, LLC - August 26, 2025

An FDA inspection of Denison Pharmaceuticals, LLC in Lincoln, RI, a contract manufacturer of dietary supplements, cosmetics, and human drug products, revealed significant deficiencies. The firm failed to follow written cleaning procedures, maintain its physical plant in a sanitary condition, and ensure proper hygienic practices by personnel. These issues collectively indicate a risk of product contamination.