FDA 483 - Indena S.p.A.
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Company
- Indena S.p.A.
- Product Type
- Drugs
ID · 7e415097-5c9d-452d-a7ae-474e4513041e