483
Amneal Pharmaceuticals of New York, LLCFDA 483 - Amneal Pharmaceuticals of New York, LLC - June 07, 2023
Record Details
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.
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ID · 9e350a01-ab3c-4788-af71-61c7956f30e1