Mibo Medical Group

CLOSEOUT LETTER Mibo Medical Group MARCS-CMS 558900 — November 21, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 12/05/2019 Regulated Product(s) Medical Devices