FDA WARNING_LETTER - Unomedical Device S.A. de C.V. - August 08, 2025

The FDA issued a Warning Letter to Unomedical Device S.A. de C.V., a manufacturer of insulin infusion sets, following a Remote Regulatory Assessment conducted from July 23 to August 8, 2025, in Reynosa, Mexico. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), specifically the Quality System Regulation (21 CFR Part 820) and Medical Device Reporting (21 CFR Part 803).

Key Quality System violations include the failure to validate critical manufacturing processes, such as the water leak test, despite over 5,000 leak-related complaints linked to hyperglycemia and diabetic ketoacidosis. The company also failed to adequately investigate over 41,000 complaints, some involving death, due to missing lot numbers, and demonstrated deficiencies in its Corrective and Preventive Action (CAPA) procedures, leading to ineffective resolutions and a Class I Recall.

Additionally, Unomedical Device S.A. de C.V. violated Medical Device Reporting requirements by failing to submit timely reports for multiple serious injuries and malfunctions, some involving device leakage leading to hyperglycemia, within the mandated 30-day timeframe. The FDA deemed the company"s responses inadequate, requiring a comprehensive plan to address systemic problems, assess risks of distributed products, and provide evidence of implemented corrective actions within 15 business days.