Inspections, Compliance, Enforcement, and Criminal Investigations
Herman's Bakery - Close Out Letter 12/13/2012
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7132
FAX: (612) 334-4142
December 13, 2012
Herman A. Oestreich
130 Main Street South
Cambridge, Minnesota 55008-1621
Dear Mr. Oestreich:
We received your March 6, 2012, letter in response to Warning Letter MN 12-25. Your letter has been made a part of the Minneapolis District's permanent file for your firm.
The Food and Drug Administration has completed an evaluation of your corrective actions in response to the Warning Letter. Based on our evaluation, it appears that you have addressed the violations contained in the 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.
If you have questions about this letter, please contact me at (612)758-7132.
Brian D. Garthwaite, Ph. D.