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CLOSEOUT LETTER

Clinicon Corp MARCS-CMS 582801 —

Product:
Medical Devices

Recipient:
Recipient Name
Mr. Fritz A. Brauer
Recipient Title
President / CEO
Clinicon Corp

3025 Industry St.
Ste. A
Oceanside, CA 92054
United States

ccfab7@clinicon.com
Issuing Office:
Division of Medical Device and Radiological Health Operations West

United States


Dear Mr. Brauer:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #582801 dated June 20, 2019]. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
Jessica Mu
Director of Compliance Branch
Office of Medical Device and Radiological Health
Division 3/West

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