FDA 483 - Cosmetic Essence, Inc. - December 06, 2024

During an inspection conducted from December 4-6, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Cosmetic Essence, Inc., an over-the-counter (OTC) drug and cosmetic manufacturer. The report detailed two primary observations indicating deviations from regulatory expectations. The first observation cited a lack of adequate cleaning validation studies for non-dedicated equipment. This equipment, including various compounding tanks and filling machines, is utilized for both OTC drug and cosmetic product manufacturing. The absence of validated cleaning procedures poses a risk of cross-contamination, potentially compromising the safety, identity, strength, quality, or purity of drug products. The second critical observation highlighted a failure to thoroughly investigate and review unexplained discrepancies, particularly regarding out-of-specification (OOS) results for drug products. The firm was found to have invalidated initial OOS assay results based on retesting new samples, often without documented justification for not retesting the original problematic samples or identifying an assignable cause for the initial failure. This practice indicates shortcomings in the company's quality control and deviation management systems. Cosmetic Essence, Inc. is required to promptly address these observations by developing and implementing comprehensive corrective and preventive actions to ensure compliance with federal regulations governing pharmaceutical manufacturing.