CLOSEOUT LETTER
BioModeling Solutions, Inc. MARCS-CMS 540821 —
- Delivery Method:
- VIA Electronic Mail
- Product:
- Medical Devices
- Recipient:
-
Recipient NameKirk Huntsman
-
Recipient TitleCEO
- BioModeling Solutions, Inc.
- Vivos Therapeutics, Inc.
7921 Southpark Plaza, Ste. 210
Littleton, CO 80120
United States-
- kirk@vivoslife.com
- Issuing Office:
- Los Angeles District Office
United States
Dear Mr. Huntsman,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to Warning Letter #540821-18 dated 1/12/2018. Based on our evaluation, it appears that you have addressed the violation(s) 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
Compliance Branch Director
Office of Medical Devices and Radiological Health Operations
Division 3/West
Cc: Kim Griffith, Director of Compliance, kgriffith@vivoslife.com / Marc Sanchez, Counsel, msanchez@fdaatty.com