FDA 483 - Olon S.p.A.

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.