483
Olon S.p.A.Olon S.p.A. – FDA 483, Sep 13, 2019
Record Details
Olon S.p.A. in Rodano, Milan, Italy, was inspected by the FDA from September 9-13, 2019. The inspection revealed a significant issue regarding data integrity, specifically the firm's failure to ensure the accuracy and integrity of electronic data backed up from computerized laboratory systems. This indicates a serious lapse in data management practices for API and intermediate drug product analysis.
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ID · 4f9316f1-e641-494a-807a-a14454926a65
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