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Talk to a SpecialistTalk to a SpecialistAdvanced Cosmetic Research Laboratories Inc. manufactured unapproved new drug products, including 5% Lidocaine Cream, and failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals under 21 CFR parts 210 and 211. During an April 2022 inspection, investigators identified significant violations including failure to maintain the manufacturing facility in good repair and inadequate facility design for OTC topical drug products. The company's non-conforming methods, facilities, and controls rendered the drug products adulterated and misbranded, with the unapproved Lidocaine Cream constituting illegal introduction of an unapproved new drug into interstate commerce. The FDA had not received a detailed response to the Form FDA 483 observations at the time of the warning letter issuance.