FDA 483 - Weckerle Cosmetics USA, INC - October 31, 2025

During an inspection conducted from October 27 to October 31, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Weckerle Cosmetics USA, INC. The inspection identified several significant observations regarding the company's adherence to current Good Manufacturing Practices (cGMP). Key findings included a lack of thorough investigations into unexplained manufacturing discrepancies and customer complaints, such as product quality issues and potential contamination, with insufficient documentation of conclusions and follow-up actions. The FDA noted deviations from established production and process control procedures, specifically regarding formulation changes where re-validation and re-training were not adequately documented or performed. Additionally, the inspection revealed deficiencies in equipment cleaning and maintenance practices, with inadequate records for utensils used in compounding areas and a lack of quality oversight. In the laboratory control area, the company failed to perform microbiological testing on certain finished drug products without adequate scientific justification and did not consistently retain representative samples of active ingredients or finished products. A specific raw material was also found not to be identity tested, nor was its identity verified in the final product. These observations indicate areas where Weckerle Cosmetics USA, INC must implement comprehensive corrective and preventative actions to ensure compliance with regulatory requirements and maintain product quality and safety.