FDA 483 - Amneal Pharmaceuticals Private Ltd. - December 23, 2022

An FDA inspection of Amneal Pharmaceuticals Private Limited in Ahmedabad, Gujarat, a parenteral drug manufacturer, revealed significant deficiencies across its aseptic processing operations. The firm failed to adequately verify aseptic practices, maintain proper environmental monitoring, and ensure appropriate airflow visualization, indicating a lack of control over critical manufacturing processes. These issues collectively raise concerns about the sterility assurance and overall quality of the drug products produced.