,On 18 December 2025, the United States Food and Drug Administration (FDA), through its Center for Drug Evaluation and Research (CDER), issued a Warning Letter to Private Label Skin Care, Inc. following an inspection of its manufacturing facility in Canoga Park, California, conducted from 16 to 23 June 2025. The FDA identified significant violations of Current Good Manufacturing Practice (CGMP) regulations under 21 CFR Parts 210 and 211, resulting in the firms drug products being deemed adulterated under the Federal Food, Drug, and Cosmetic Act. Key deficiencies included the failure to establish an adequate quality control unit and insufficient oversight of contract manufacturing operations, particularly after the firm was notified of elevated impurities in certain over-the-counter (OTC) drug products. Despite notification, affected batches continued to be distributed, leading to a voluntary recall later in 2025. In addition, the FDA found that the company failed to list at least 21 human OTC drug products in the electronic Drug Registration and Listing System, rendering those products misbranded and unlawfully introduced into interstate commerce. The agency emphasized that accurate establishment registration and drug listing are critical for patient safety, inspections, and post-market surveillance. The letter also noted that some distributed products may be regulated as cosmetics and therefore subject to additional requirements, including those under the Modernization of Cosmetics Regulation Act of 2022. The FDA requested a comprehensive corrective action plan and required the firm to respond within 15 working days, warning that failure to adequately address the violations could result in enforcement actions such as product seizure, injunctions, or withholding of export certificates and application approvals.
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