FDA 483 - Cosmax USA, Inc. - December 22, 2014

An FDA inspection of Nu-World Corporation, a drug product manufacturer in Carteret, NJ, revealed several significant deficiencies. Observations included an inadequate written stability program lacking specific test methods, insufficient controls over computer systems for master production records, and a failure to investigate unexplained discrepancies. Additionally, master production and control records lacked theoretical yield statements with required investigation limits.