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CLOSEOUT LETTER

Huvepharma Inc Jan 30, 2017

Huvepharma Inc - Close Out Letter 1/30/17


Huvepharma Inc

 

  

Black HHS-Blue FDA Logo

 

 

 
Kansas City District Office
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100 

January 30, 2017
 

VIA UPS

Glen Wilkinson
President
Huvepharma, Inc.
525 West Park Dr., Suite 230
Peachtree City, GA 30269

Dear Mr. Wilkinson:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [Ref. – 2013-10, June 13, 2013], follow-up inspections dated June 3-July 2, 2014, August 17-September 1, 2015, and October 6-26, 2016, and meetings dated October 15, 2014 and February 29, 2016. Based on our evaluation, it appears that you have addressed the violations contained in the 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/

Cheryl A. Bigham
District Director
Kansas City District
 

Cc:
Brandon Clough, Quality Director
Huvepharma, Inc.
3360 Maury Ave
Saint Louis, MO 63116-2029