FDA WARNING_LETTER - Cosmetic Science Laboratories LLC - September 20, 2022

The FDA inspected Cosmetic Science Laboratories LLC from September 6-20, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. The firm manufactures sunscreens, including 4-IN-1 Broad Spectrum SPF 50, Daily Protect Sunscreen Moisturizer Broad Spectrum SPF 30, Oil Daily Protect Sunscreen Moisturizer Broad Spectrum SPF 30, and SPF-30 (b)(4).

Violations include failure to identity test incoming active pharmaceutical ingredients (APIs) and validate supplier COAs (21 CFR 211.84(d)(1) and 211.84(d)(2)). The firm also lacked adequate written procedures for production and process control, specifically regarding process validation, complete batch production records, cleaning validation for shared equipment, and a properly designed and monitored water system (21 CFR 211.100(a) and 21 CFR 211.188). The quality control unit failed to ensure CGMP compliance, lacking oversight for OOS results, deviations, annual product reviews, and CGMP training, and using inadequate hold-time studies (21 CFR 211.22).

Additionally, Cosmetic Science Laboratories LLC failed to register their establishment annually and list all manufactured drugs with the FDA, making their products misbranded. Although the firm stated they ceased drug production and deregistered