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  5. Provitus Dabrowscy, Malesa S.J. - 433918 - 11/22/2019
  1. Warning Letters

CLOSEOUT LETTER

Provitus Dabrowscy, Malesa S.J. MARCS-CMS 433918 —

Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Stanislaw Dabrowski
Recipient Title
Owner
Provitus Dabrowscy, Malesa S.J.

ul. Weteranów 149
05-250 Radzymin
Poland

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

5001 Campus Drive
College Park, MD 20740
United States


Dear Mr. Dabrowski:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #433918, issued on July 17, 2014 and your firm’s petitions to be removed from the Red List of Import Alert #99-38. 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.

Sincerely,
/S/
Robyn R. Jones
Team Lead
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition

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