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CLOSEOUT LETTER

Tenex Health 28/09/2017

Tenex Health - Close Out Letter 9/28/17


Tenex Health

 

  

Black HHS-Blue FDA Logo

 

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

 
 

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

September 28, 2017

Robert L. Mitchell, C.O.O. and VP QA/RA
Tenex Health, Inc.
26902 Vista Terrace
Lake Forest, CA 92630

Dear Mr. Mitchell:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL # 25-12), dated 06/14/2012. 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
Compliance Branch Director
Division 3/West
Office of Medical Device and Radiological Health Operations