FDA 483 - Omya, Inc - May 27, 2022

An FDA inspection of Omya Inc., an API manufacturer in Superior, AZ, revealed significant deficiencies in computerized system controls and quality unit oversight. The firm failed to establish appropriate controls over electronic data, including signature removal, access permissions, data deletion, and backup schedules. Additionally, the quality unit was not adequately notified of production equipment alerts and preventative maintenance work orders, hindering their ability to investigate potential quality deficiencies.