Unomedical Device S.A. de C.V. Warning Letter Details

Summary

Unomedical Device S.A. de C.V., a Mexican manufacturer of insulin infusion sets sold under multiple brand names including MiniMed and Convatec products, was found to be manufacturing adulterated devices in violation of Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. An FDA remote regulatory assessment conducted in July-August 2025 determined that the company's manufacturing methods, facilities, and controls did not conform to Quality System Regulation standards required for medical devices. The company submitted responses to FDA observations on three separate occasions between August and November 2025.