Amneal Pharmaceuticals Inc. – FDA 483, Jun 7, 2023

Amneal Pharmaceuticals of New York, LLC, a prescription and OTC drug manufacturer, received five observations during an FDA inspection. The firm was cited for failures in quality control, including inadequate investigation of out-of-specification results, lack of equipment qualification and calibration, and absence of proper cleaning procedures. These issues indicate significant deficiencies in the firm's quality systems and adherence to regulatory requirements.