FDA 483 - Classic Cosmetics, LLC - October 24, 2025

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from October 20-24, 2025, the firm identified as 'Manufacturer' received a Form FDA 483, detailing significant observations related to its drug manufacturing operations. The inspection highlighted several critical issues, primarily concerning quality control and equipment management, indicating potential non-compliance with current Good Manufacturing Practices (cGMP) for drug products under the Federal Food, Drug, and Cosmetic Act.

Key violations included the absence of complete identity testing for various drug components used in OTC drug production, such as specific batches of (b)(4) and (b)(4). Furthermore, essential manufacturing equipment, including Molding equipment No. (b)(4) and Filling equipment No. (b)(4), lacked proper installation, operational, and performance qualifications (IQ, OQ, PQ) to ensure their suitability for intended use. A significant concern was also raised regarding the failure to establish written cleaning and maintenance procedures, specifically a cleaning validation plan, for shared equipment used for both OTC drugs and cosmetic products. This omission poses a risk of cross-contamination.

The 'Manufacturer' is required to address these inspectional observations by implementing appropriate corrective and preventive actions and submitting a timely response to the FDA.