FDA 483 - Evi Labs - January 15, 2025

Evi Labs LLC in Medley, FL, received a Form 483 with 10 observations following an inspection from January 9-15, 2025. The inspection revealed significant deficiencies across laboratory controls, facilities and equipment, materials, production, and quality systems, indicating a pervasive lack of fundamental cGMP compliance. Key issues include inadequate product testing, lack of stability data, poor data integrity controls, and insufficient quality unit oversight for OTC drug manufacturing.