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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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

Public Health Service
Food and Drug Administration
  New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896
 

February 25, 2010


Mr. Joseph Petrowski, CEO
Cumberland Farms, Inc.
100 Crossing Boulevard
Framingham, Massachusetts 01702


Dear Mr. Petrowski:

The Food and Drug Administration conducted an inspection at your Westborough, MA facility on January 25, 2010 and January 27, 2010. The purpose of this inspection was to verify corrective actions in response to our Warning Letter NWE-16-09W dated September 11, 2009, At the conclusion of this inspection you were issued a FDA-483, List of Inspectional Observations dated January 27, 2010. We acknowledge receipt of your letter of February 12, 2010 and find that the corrective actions which you propose, once they are fully implemented, should adequately address the observations made by our investigator.

Based on our evaluation of this inspection and your response to the FDA-483, Inspectional Observations, it appears that you have addressed the violations contained in Warning Letter NWE-16-09W. 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/
Lori A. Holmquist
Compliance Officer
New England District Office
Augusta Maine Resident Post

cc: Mr. Michael R. McGloin
Cumberland Farms, Inc.
156 Flanders Road
Westborough, MA 05181-1032