FDA 483 - Amneal Pharmaceuticals of New York, LLC - March 18, 2019

Amneal Pharmaceuticals of New York, LLC in Hauppauge, NY, was inspected by the FDA from March 5-18, 2019, and received one observation. The inspection revealed a significant issue with inadequate humidity control in the warehouse, affecting the storage conditions of empty hard gelatin capsules used in drug manufacturing. This deficiency could compromise the identity, strength, quality, and purity of drug products.