FDA 483 - G S Cosmeceutical USA Inc - December 03, 2015

G S Cosmeceutical USA Inc, a contract drug manufacturer in Livermore, CA, was cited for significant deficiencies in its quality systems during an FDA inspection. Observations included failures in equipment cleaning validation, out-of-specification investigations, process validation, stability testing, and water system monitoring. Several issues, including OOS investigations and process validation, were repeat observations from a previous inspection, indicating persistent non-compliance.