FDA 483 - Cosmax USA, Inc. - September 20, 2017

An FDA inspection of Nu-World Corporation, an OTC drug manufacturer in Carteret, NJ, revealed significant deficiencies in their quality systems. The firm failed to thoroughly investigate out-of-specification product yields and lacked adequate controls over computer systems and change management. Additionally, the inspection found a lack of GMP training for contract employees and insufficient long-term stability studies to support product expiration dates.