FDA 483 - Catalent Anagni SRL - July 16, 2024

Catalent Anagni Srl, a drug product manufacturer in Anagni, Italy, was cited for significant deficiencies across its sterile manufacturing operations. Observations included inadequate procedures for preventing microbiological contamination, deficient environmental monitoring, and insufficient qualification of visual inspection and cleaning processes. These issues indicate a lack of robust controls over critical aspects of sterile drug product manufacturing and quality assurance.