FDA 483 - QOL Medical LLC - January 09, 2026

QOL Medical, LLC in Clearwater, FL, a drug substance manufacturer, was cited for significant deficiencies across its manufacturing and quality systems. The inspection revealed inadequate process validation, poor contamination control, lack of quality oversight, and issues with electronic data systems and laboratory controls. These findings indicate a systemic failure to ensure the quality, purity, and safety of their drug products.