CLOSEOUT LETTER

Brower Enterprises December 05, 2014

Recipient:: Brower Enterprises; United States

Issuing Office:: United States


Department of Health and Human Services
	Food and Drug Administration Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 758-7132 Fax: (612) 334-4142

December 5, 2014

Stanley D. Brower
Barbara Brower
Co-owners
Brower Enterprises
1002 E. Fifth Street
Canton, South Dakota 57013-1925

Dear Mr. and Mrs. Brower:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter MIN 13-24 dated September 9, 2013. 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/

Brian D. Garthwaite, Ph.D.
Compliance Officer
Minneapolis District

BDG/ccl

Department of Health and Human Services