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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Freskeeto Frozen Foods, Inc. - Close Out Letter 10/7/13

  

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

 
 New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433

 

October 7, 2013


Mr. Gary J. Dickman
President / Co-Owner
Freskeeto Frozen Foods, Inc.
8019 Route 209
P.O. Box 547
Ellenville, NY 12428-5615


Dear Mr. Dickman,

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to Warning Letter NYK-2013-15 issued to you on April 18, 2013. Based on our evaluation of your written responses and follow-up inspection, 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/

LCDR Frank Verni, USPHS
Compliance Officer
FDA-New York District


O: addressee
cc: Mr. Scott S. Dickman, Vice President / Co-Owner