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# QS Issues at MiBo Medical Group
- URL: https://www.fdaweb.com/qs-issues-at-mibo-medical-group/
- Published: 2018-12-04T12:00:00.000Z
- Updated: 2026-09-15T00:48:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142953

A 5/7-5/10 FDA inspection at MiBo Medical Group, Dallas, TX, found Quality System Regulation violations in the firm’s manufacturing of the MiBo Thermoflo. An 11/20 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm627111.htm?ref=fdaweb.com) says specific violations were: 

- failing to establish procedures for design control;
- failing to establish procedures for corrective and preventive actions;
- failing to establish procedures to ensure all purchases or otherwise received product and services conform to specified requirements;
- failing to establish procedures for finished device acceptance;
- failing to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to develop, maintain, and implement written medical device reporting procedures;
- failing to establish a device master record;
- failing to establish and maintain procedures for quality audits and to conduct such audits to assure that the quality system complies with the established quality system requirements and to determine quality system effectiveness; and
- failure of management with executive responsibility to establish its policy and objectives for, and commitment to, quality.

The agency acknowledges the firm’s commitment to developing procedures and notes it has not provided objective evidence of corrections made and thus FDA cannot evaluate the adequacy of its responses.

MiBo was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of each correction and a timetable for completion.