Inspections, Compliance, Enforcement, and Criminal Investigations
Dawn's Foods, Inc. - Close Out Letter 3/18/14
Department of Health and Human Services
|Food and Drug Administration|
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7210
FAX: (612) 334-4142
March 18, 2014
James J. Soderholm
Dawn's Foods, Inc.
1530 La Dawn Drive
Portage, Wisconsin 53901-8823
Dear Mr. Soderholm:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter MIN 11-26 dated May 12, 2011. 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.
Demetria L. Lueneburg