Gussyup LLC (dba Private Label Grooming) – FDA 483, Feb 20, 2025

The FDA conducted an inspection of Ecghancemeres from February 18-20, 2025, revealing significant deficiencies related to drug manufacturing and quality control, under the Federal Food, Drug, and Cosmetic Act. Key violations observed include a lack of essential testing for over-the-counter (OTC) finished drug products, specifically concerning chemistry and microbiology to ensure potency and purity. The company failed to provide scientific justification for product expiration dates, lacking stability studies, and had issues with inaccurate or unreadable printed expiry information. Furthermore, the inspection identified a critical absence of a functioning quality control unit responsible for oversight, approval, and rejection of drug products. The firm demonstrated a lack of written procedures for critical operations such as product testing, specifications, rework, and investigations into failed batches or out-of-specification results. There was also a notable failure to record and investigate deviations, manage change controls, and properly review production records. Regarding component quality, the facility did not test purified water used in drug compounding for chemical or microbiological quality. Active pharmaceutical ingredients and key raw materials were not tested to confirm supplier certificates of analysis, risking the quality of commercially sold OTC products. The company must implement comprehensive quality systems, establish robust testing protocols, scientifically justify expiration dates, and develop a fully functional quality control unit to address these compliance concerns.