FDA 483 - Evi Labs - January 15, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · ea556423-6b1d-42b1-bdcc-1c6022921cac