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

An FDA inspection of Private Label Skin Care Inc. in Canoga Park, CA, revealed significant quality control failures. The firm continued to distribute OTC drug products contaminated with benzene, a known carcinogen, after receiving test results indicating levels above acceptable limits. Additionally, the company failed to conduct proper investigations into these discrepancies and lacked established annual product review procedures for its OTC drug products.