483
Amneal Pharmaceuticals of New York, LLCAmneal Pharmaceuticals of New York, LLC – FDA 483, Mar 18, 2019
Record Details
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.
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ID · 0a34426e-a08e-4d2a-a71a-182146fa7281
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