FDA WARNING_LETTER - Handock Cosmetics Co., Ltd. - March 24, 2023

The FDA issued a Warning Letter to Handock Cosmetics Co., Ltd. following an inspection from March 20-24, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated. The company's Hand Sanitizer Perfect Care Gel was also cited as an unapproved new drug and misbranded, along with Dr. Clean Perfect Gel being misbranded.

Key violations include: 1. Failure to conduct identity testing for drug product components and validate supplier test analyses (e.g., ethanol). 2. Quality control unit's failure to ensure CGMP compliance and meet specifications, lacking procedures for critical oversight operations (e.g., OOS results, CAPA, supplier qualification, annual product reviews). 3. Failure to use appropriately designed and maintained equipment, lacking evidence of qualification, maintenance, or calibration for manufacturing equipment, water systems, and analytical instruments.

The Hand Sanitizer Perfect Care Gel was deemed an unapproved new drug due to the "sterilizing effect" claim, which deviates from the Tentative Final Monograph for OTC antiseptic rubs. Both Hand Sanitizer Perfect Care Gel and Dr. Clean Perfect Gel were misbranded for lacking a complete domestic address or telephone number for adverse event reporting. Hand Sanitizer Perfect Care Gel was additionally misbranded for non-compliance with Section 505G of the FD&C Act.

The FDA noted repeat violations from