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  5. Merges, Brian J - Close Out Letter 4/5/18
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CLOSEOUT LETTER

Merges, Brian J


Recipient:
Merges, Brian J


United States

Issuing Office:

United States


 

  

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Office of Human and Animal Food- West Division II
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100 

April 5, 2018

DELIVERY VIA UPS

WARNING LETTER CLOSE-OUT LETTER

Mr. Brian J. Merges
7777 Old Highway Road
Peosta, IA 52068
CMS Case: 519383

Dear Mr. Merges:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 519383) on March 17, 2017. 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/

Andrew A. Hoopes
Compliance Officer
Office of Human and Animal Food-West Div. 2