483
Amneal Pharmaceuticals Private Ltd.FDA 483 - Amneal Pharmaceuticals Private Ltd. - December 23, 2022
Record Details
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.
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ID · b6047e86-e443-40b8-8261-c624ee2c233e