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CLOSEOUT LETTER

Montana Fish Company 20/10/2014

Montana Fish Company - Close Out Letter 10/20/14


Montana Fish Company

  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 Food and Drug Administration
Seattle District
Pacific Region
22215 26th Ave Drive SE, Suite 210
Bothell, WA 98021-4421

Telephone: 425-302-0340
           FAX: 425-302-0402

 

October 20, 2014


OVERNIGHT DELIVERY
SIGNATURE REQUIRED


Travis I. Byerly
President
Montana Fish Company
1401 Gold Avenue, Suite 2B
Bozeman, Montana 5975-2403


Dear Mr. Byerly:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter SEA 14-10, dated April 10, 2014. 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/

Miriam R. Burbach
District Director