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CLOSEOUT LETTER

Jonathan S. Allgyer Jan 13, 2015

Jonathan S. Allgyer - Close Out Letter 1/13/15


Jonathan S. Allgyer

  

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

 
 Food and Drug Administration
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7112
FAX: (612) 334-4142

January 13, 2015


Jonathan S. Allgyer
Owner
21472 Ames Branch Road
Shullsburg, Wisconsin 53586-9713


Dear Mr. Allgyer:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter MIN 14-10 dated March 17, 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/

Christopher vanTwuyver
Director Compliance Branch
Minneapolis District

 

CVT/ccl