U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Brower Enterprises - Close Out Letter 12/5/14
  1. Warning Letters

CLOSEOUT LETTER

Brower Enterprises


Brower Enterprises

  

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) 758-7132
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