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# Quality System Issues at Koven Technologies
- URL: https://www.fdaweb.com/quality-system-issues-at-koven-technologies/
- Published: 2026-08-04T12:00:00.000Z
- Updated: 2026-09-14T13:44:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161572

A 2/2-2/6 FDA inspection at Koven Technologies in St. Louis, MO, found Quality Management System Regulation (QSMR) violations in the firm’s production and/or marketing of the Bidop 3 Doppler. A just-released 7/21 Warning Letter lists these violations:

- failure to document procedures to control design and development changes and determine the significance of these changes to function, performance, usability, safety, and regulatory requirements for the medical device and its intended use;
- failure to document one or more processes for risk management in product realization and determine, as appropriate, quality objectives and requirements for the product;
- failure to establish criteria for the evaluation and selection of suppliers; and
- failure to maintain records of the review, evaluation, and investigation for any complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications.

FDA says the adequacy of the firm’s responses to the inspection observations cannot be determined at this time while corrective actions are underway. Koven was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of each action and a schedule for completing the corrections.