FDA 483 - Private Label Skin Care Inc. - June 23, 2025

During an FDA inspection conducted from June 16-23, 2025, an unnamed firm received a Form FDA 483 detailing significant observations concerning its quality systems for over-the-counter (OTC) drug products. The most critical issue involved the continued distribution of OTC drug products contaminated with benzene, a known human carcinogen, between April and June 2024. This occurred despite the firm being notified on April 15, 2024, that assay testing results confirmed benzene levels exceeded acceptable limits. Additionally, the inspection revealed a failure to adequately investigate these discrepancies, as the firm did not expand its investigation into other potentially affected batches of the same drug product, even after five specific lots were identified with elevated benzene. Compounding these deficiencies, the firm lacked established written procedures for, and did not perform, annual product reviews for its OTC drug products. These observations indicate a deviation from fundamental good manufacturing practices and regulatory requirements under the Federal Food, Drug and Cosmetic Act, necessitating prompt and comprehensive corrective actions to ensure product quality and consumer safety.