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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Bednareck Brothers - Close Out Letter 11/22/11


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) 758-7133
FAX: (612) 334-4142

November 22, 2011

John L. Bednarek
Tom Bednarek
Bob Bednarek
Bednarek Brothers
N 283 Ruby Drive
Stetsonville, Wisconsin 54480

Dear Mssrs. Bednarek:

We received your September 24, 2011, letter in response to Warning Letter MIN 11-54. 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.
Compliance Officer
Minneapolis District