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  1. Warning Letters

CLOSEOUT LETTER

MEDDEV USA, INC.

Recipient:
MEDDEV USA, INC.

United States

Issuing Office:

United States

 

  

Black HHS-Blue FDA Logo

 

Office of Medical Device and Radiological Health, Division 3 West
19701 Fairchild
Irvine, California 92612 

 
 

November 2, 2017

UPS OVERNIGHT MAIL

Jolie G. Slaton
Owner and President
MEDDEV USA, Inc.
7700 Greenway Blvd #I-308
Dallas, Texas 75209

Dear Ms. Slaton:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, 2013-DAL-WL-03, issued on October 9, 2012. 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/

Kelly D. Sheppard, M.S., BME
Director, Compliance Branch
Office of Medical Device and Radiological Health Operations, Division 3 West
 

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