FDA 483 - COSMETIC LABORATORY INC - March 10, 2026

From March 5 to March 10, 2026, the FDA conducted an inspection of Cosmetic Laboratory Inc, a contract manufacturer located in Downey, California. The inspection identified several critical violations of manufacturing standards under the Federal Food, Drug, and Cosmetic Act. Key issues included a failure to validate manufacturing processes, resulting in no assessment of batch-to-batch consistency for over-the-counter (OTC) products. Additionally, the facility failed to perform performance qualifications on essential equipment such as filling machines and tanks. Equipment maintenance was also found lacking, as weighing scales were not calibrated by qualified external services as required by the firm"s own procedures. Furthermore, the quality control unit failed to follow protocols for qualifying raw material vendors and, most significantly, allowed the use of subpotent ingredients in the production and commercial release of drug products. These observations serve as a formal notice of objectionable conditions. To address these findings, Cosmetic Laboratory Inc is required to review the observations and submit a written response to the FDA. This response should include detailed corrective actions the firm has taken or plans to implement to rectify the identified deficiencies and ensure future compliance with safety regulations.