Intercos Europe S.p.A – FDA Warning Letter, Mar 15, 2024

On August 15, 2024, the FDA issued a Warning Letter to Intercos Europe S.p.A. following an inspection from March 11-15, 2024, at their Agrate Brianza, Italy facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to test components for identity and conformity (21 CFR 211.84(d)(1) and 211.84(d)(2))**: The firm manufactured OTC sunscreen drug products without adequately testing incoming raw materials, such as glycerin, for identity (e.g., DEG/EG contamination) and other specifications. They also relied on supplier Certificates of Analysis (COAs) without validating their reliability. The firm's response was deemed inadequate due to a lack of updated procedures, insufficient demonstration of supplier reliability, and no retroactive risk assessment for distributed products containing high-risk components. 2. **Failure to investigate unexplained discrepancies or batch failures (21 CFR 211.192)**: The firm failed to adequately investigate multiple microbial excursions in their (b)(4) system used for drug product manufacturing, including a July 26, 2023,