FDA 483 - G S Cosmeceutical USA Inc - August 14, 2019

G S Cosmeceutical USA Inc, an OTC/Rx drug manufacturer in Livermore, CA, was cited with six observations during an FDA inspection from August 12-14, 2019. The inspection revealed significant deficiencies in quality control unit procedures, GMP training, process validation, equipment qualification, facility space management, and equipment cleaning protocols. These issues indicate a lack of adherence to current Good Manufacturing Practices, posing potential risks to drug product quality and purity.