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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Smak Sp. z o.o. - Close Out Letter 11/02/2012


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

Public Health Service
Food and Drug Administration
 Washington, DC

November 2, 2012

Mr. Tomasz Pruszynski
Production Director
Smak Sp. z o.o. c/o
Prymat Sp. z o.o.
Chlebowa 14
44-337 Jastrzebie Zdroj

Dear Mr. Pruszynski:


The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #301958, issued May 15, 2012. Based on our evaluation, it appears 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.




Robyn R. Jones
Compliance Officer
Office of Compliance
Center for Food Safety
and Applied Nutrition