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  1. Warning Letters

CLOSEOUT LETTER

Mibo Medical Group MARCS-CMS 558900 —

Delivery Method:
United Parcel Service
Product:
Medical Devices

Recipient:
Recipient Name
Michael Whitehurst
Recipient Title
CEO
Mibo Medical Group

2526 Manana Road
Suite 105
Dallas, TX 75220
United States

Issuing Office:
Office of Medical Device & Radiological Health Operations Division 3/West

United States


Dear Mr. Whitehurst:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #558900, November 20, 2018). Based on our evaluation, it appears that your firm has 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

Medical Device & Radiological Health Operations

Division 3/West