FDA WARNING_LETTER - Advanced Cosmetic Research Laboratories Inc. - April 27, 2022

The FDA inspected Advanced Cosmetic Research Laboratories Inc. from April 21-27, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR parts 210 and 211, rendering their drug products adulterated. The firm failed to maintain its facility in a good state of repair (21 CFR 211.58). Additionally, the quality control unit failed to ensure CGMP compliance and meet product specifications (21 CFR 211.22(a) and (d)), lacking adequate procedures for complaint handling and Out-of-Specification (OOS) investigations. The firm did not record or investigate complaints, nor did it maintain a list of OOS results, despite numerous OOS findings at their contract testing laboratory. Furthermore, their (b)(4) 5% LIDOCAINE CREAM was identified as an unapproved new drug, violating section 505(a) of the FD&C Act, because its lidocaine concentration (5%) exceeds the allowable OTC monograph limit (0.5-4%). This product is also misbranded under section 502(ee) of the FD&C Act for not complying with section 505G requirements. The FDA requires a comprehensive assessment and remediation plan for the Quality Unit, ensuring adequate authority, resources, robust procedures, and oversight, with a response due within 15 working days. Failure to address these violations may lead to regulatory actions, including seizure, injunction, and impact on future approvals or export certificates.