FDA 483 - Olon S.p.A. - September 13, 2019

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.