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CLOSEOUT LETTER

Mega Pro International Aug 31, 2018

Mega Pro International - Close Out Letter 8/31/18


Recipient:
Mega Pro International


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
U.S. Food and Drug Administration
6th Ave & Kipling St, DFC Bldg 20
PO Box 25087
Denver, CO 8022-0087 

August 31, 2018

VIA UPS OVERNIGHT

David V. Smith, Owner
Mega-Pro Nutrition, Inc.
251 Hilton Drive
St George, UT 84 790

Dear Mr. Smith:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter HAF4W(DEN)-17-17-WL dated August 25, 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. 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/

LaTonya M. Mitchell
Program Division Director
Office of Human and Animal Food Operations -
Division IV West