FDA WARNING_LETTER - Active Cosmetics Manufacturing Inc - October 31, 2025

Active Cosmetics Manufacturing Inc. received an FDA warning letter on April 22, 2026, following an inspection of its Orlando facility from October 27 to 31, 2025. The FDA determined that the company’s drug products are adulterated due to significant violations of Current Good Manufacturing Practice (CGMP) regulations under the Federal Food, Drug, and Cosmetic Act. The primary issues identified involve the company’s failure to thoroughly investigate batches that failed microbiological testing. Specifically, the firm released products despite findings of harmful bacteria by relying on passing retest results without identifying the root cause of the initial failures. Additionally, the FDA noted that the company used rapid testing methods that were never properly validated to ensure they were as accurate as standard industry methods. There were also critical failures in material oversight; the company did not adequately verify the identity of raw materials or test high-risk ingredients for hazardous contaminants, posing a significant safety risk. To address these violations, Active Cosmetics Manufacturing Inc. must hire an independent consultant to evaluate their operations. The company is required to submit a comprehensive remediation plan, conduct a retrospective review of previous test results, and perform a risk assessment for products already on the market. Failure to correct these systemic flaws may result in legal action, including product seizures or injunctions.