FDA 483 - Nesher Pharmaceuticals (USA) LLC - October 20, 2019

An FDA inspection of Nesher Pharmaceuticals (USA) LLC in Bridgeton, MO, revealed significant deficiencies across multiple areas of their drug manufacturing operations. The firm failed to adequately validate test methods, thoroughly investigate out-of-specification results and product complaints, and maintain proper controls over computer systems. These issues indicate a lack of adherence to cGMP regulations, posing potential risks to product quality and patient safety.