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# Quality System Violations at ITG-Medev
- URL: https://www.fdaweb.com/quality-system-violations-at-itg-medev/
- Published: 2018-09-18T12:00:00.000Z
- Updated: 2026-09-15T00:32:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142373

A 6/1-6/6 FDA inspection at ITG-Medev, San Francisco, CA, found Quality System regulation violations in the firm’s manufacturing of Omiderm, a wound dressing product. A 9/7 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm620237.htm?ref=fdaweb.com) says that specific violations were: 

- failing to ensure processes whose results cannot be fully verified by subsequent inspection and test have been validated according to established procedures;
- failing to document acceptance activities;
- failing to establish procedures for implementing corrective and preventive action;
- failing to establish procedures to control product that does not conform to specified requirements;
- failing to establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
- failing to maintain complaint files; and
- failing to establish and maintain procedures for quality audits and to conduct such audits to assure the quality system complies with the established quality system requirements and to determine quality system effectiveness.

The company was told to respond with a list of steps the firm has taken to correct the violations and prevent their recurrence, with documentation of each step and a timetable for completion.