FDA 483 - EUROSIREL S.P.A - May 24, 2024

An FDA inspection of EUROSIREL S.P.A, an OTC Drug-Device Manufacturer in Cusago, Milan, revealed multiple deficiencies. Observations included inadequate component identification testing, lack of second-person verification for component additions, incomplete batch production records, and insufficient equipment logs. Additionally, the firm failed to exercise strict control over labeling operations, indicating significant issues in quality control and manufacturing processes.