483
Olon S.p.A.FDA 483 - Olon 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.
Record Details
An FDA inspection of Olon S.p.A in Dorno, Italy, from May 21-23, 2018, identified a significant issue regarding record-keeping. The firm failed to maintain adequate records for equipment use, cleaning, and sanitization, which prevented the evaluation of potential cross-contamination risks for multi-use equipment involved in API processing. This deficiency indicates a lack of control over manufacturing processes and raises concerns about product quality and safety.
- Company
- Olon S.p.A.
- Product Type
- Drugs
Open in Dashboard
ID · bf1c3ae0-5de7-4c9a-9f3e-a14f2184ac8a