Dermazone LLC – FDA 483, Dec 6, 2022

An FDA inspection of Dermazone Solutions, Inc., a drug manufacturer, revealed significant deficiencies in its quality control unit, laboratory testing methods, and investigation processes. The firm failed to adequately review production records, verify changes to analytical methods, and ensure complete investigations into out-of-specification results. These issues led to the distribution of a drug product with an incorrect expiration date that later failed testing, highlighting serious concerns regarding product quality and compliance.