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# QS, MDR Violations at Mexico’s Unomedical Device
- URL: https://www.fdaweb.com/qs-mdr-violations-at-mexicos-unomedical-device/
- Published: 2026-02-03T12:00:00.000Z
- Updated: 2026-09-14T15:32:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160592

An FDA review of records submitted at the agency’s request by Unomedical Device in Reynosa, Tamaulipas, Mexico, identified Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of infusion sets for subcutaneous insulin delivery in diabetic patients. A just-released 1/8 Warning Letter says the specific violations were:

- failure to validate processes whose results cannot be fully verified by subsequent inspection and test;
- failure to adequately review and investigate complaints involving the possible failure of a device to meet any of its specifications;
- failure to establish and maintain procedures for implementing corrective and preventive action;
- failure to report required information no later than 30 days after the firm received or otherwise became aware of information from any source reasonably suggesting that a device that the firm markets may have caused or contributed to a death or serious injury; and
- failure to report required information no later than 30 days after receiving or otherwise becoming aware of information from any source reasonably suggesting that a device the firm markets has malfunctioned, and the device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

FDA says the firm’s responses to the inspection observations were inadequate. Unomedical was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of each step and a schedule for completing the corrections.