FDA 483 - Indena S.p.A.

An FDA inspection of Indena S.p.A, an API manufacturer in Settala, Italy, revealed significant deficiencies in their quality system. The firm failed to adequately investigate repeated deviations and out-of-specification (OOS) results, implement appropriate corrective actions, and ensure data integrity for manual entries. Recurring LAL endotoxin OOS results were not thoroughly investigated, and an instrument malfunction deviation lacked proper event capture, justification of actions, and impact assessment.