FDA WARNING_LETTER - Private Label Skin Care Inc. - June 23, 2025

The FDA issued a Warning Letter to Private Label Skin Care, Inc. following an inspection of its Canoga Park, CA facility from June 16 to 23, 2025. The letter outlines significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211) for finished pharmaceuticals, resulting in adulterated drug products under the Federal Food, Drug, and Cosmetic Act. A key violation involved the company"s inadequate quality control unit, which failed to properly oversee manufacturing. Specifically, the firm continued distributing batches of a drug product with elevated impurity levels, despite notification from its contract manufacturer, leading to a voluntary recall. The quality unit also failed to assess the impact on other products on the market. Furthermore, Private Label Skin Care, Inc. failed to provide required drug listings for at least 21 of its human over-the-counter drugs, violating section 510(j) of the FD&C Act and 21 CFR Part 207, rendering these products misbranded. Required actions include a comprehensive assessment and remediation plan for the quality control unit, testing retain samples of all affected drug products on the market with prompt corrective actions if necessary, and fulfilling all outstanding drug listing obligations.