483
Olon S.p.A.Olon S.p.A. – FDA 483
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
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ID · bf1c3ae0-5de7-4c9a-9f3e-a14f2184ac8a
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