Inspections, Compliance, Enforcement, and Criminal Investigations

BioTE Medical - Close Out Letter 5/3/18

 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Human and Animal Food Operations West Division 3
4040 North Central Expressway, Suite 300
Dallas, Texas 75204

May3, 2018

UPS OVERNIGHT

Dr. Gary S. Donovitz, Principal-Owner & Chairman
BioTe Medical, LLC
1875 W. Walnut Hill Lane, Suite 100
Irving, Texas 75038

Dear Dr. Donovitz:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 2017-DAL-WL-19 dated May 22, 2017. 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. If you choose to reestablish or sale your operations, 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 E. Hensley
Director of Compliance Branch, OHAF-W3

Page Last Updated: 05/07/2018
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