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  5. Bellus Medical - 08/16/2018
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CLOSEOUT LETTER

Bellus Medical

Product:
Medical Devices
Recipient:
Bellus Medical

United States

Issuing Office:

United States

 

   

Black HHS-Blue FDA Logo

 

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

August 16, 2018

CMS: 495955
 

UPS Overnight

Joseph L. Proctor, President/CEO
Bellus Medical, LLC.
4505 Excel Parkway, Suite #100
Addison, Texas 75001

Dear Mr. Proctor:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 2016-DAL-WL-34, dated September 13, 2016. 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/

Kelly D. Sheppard
Director, Compliance Branch 

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