FDA 483 - Combe Products, Inc. - November 06, 2025

During an inspection conducted from November 3 to November 6, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to firm "A". The inspection revealed significant concerns regarding the company's quality control and laboratory practices, specifically related to the manufacturing of certain cream products. The primary observation highlighted a failure to establish scientifically sound and appropriate specifications and test procedures to ensure drug product quality. For creams containing a specific active pharmaceutical ingredient, the firm lacked documented test methods and specifications for impurities during both product release and stability testing. This indicated a failure to adequately demonstrate that potential degradation products and manufacturing-related impurities would remain within acceptable limits throughout the product's shelf life. Furthermore, the inspection noted that for creams utilizing a preservative, the laboratory did not have a defined test method or specification to verify that the preservative concentration remained within acceptable limits over the product's shelf life. These observations suggest deficiencies in adhering to regulatory expectations for Good Manufacturing Practices (GMP), particularly concerning quality system controls and laboratory testing for drug products. Firm A is expected to address these findings by developing and implementing comprehensive corrective and preventive actions to ensure product identity, strength, quality, and purity.