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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Schwarz Fish Company - Close Out 4/13/12

  

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

Public Health Service
Food and Drug Administration
 Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142

April 13, 2012

Leslie L. Winter
Manager
Schwarz Fish Company
3028 South Ninth Street
Sheboygan, Wisconsin 53081

Dear Ms. Winter:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter MIN 10-02 dated October 16, 2009. 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/

Tyra S. Wisecup
Compliance Officer
Minneapolis District