FDA 483 - Latina Pharma S.p.A.

An FDA inspection of Corden Pharma Latina S.p.A. in Sermoneta, Italy, revealed significant deficiencies across its quality, production, and laboratory systems. The firm failed to thoroughly investigate discrepancies, maintain adequate aseptic processing controls, validate reprocessing procedures, ensure reliable laboratory data, and properly validate test methods for sterile injectable products. These issues indicate a serious lack of control over manufacturing processes and product quality.