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  5. Sunny Creek Farm Inc. - 617664 - 12/08/2022
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Sunny Creek Farm Inc. MARCS-CMS 617664 —

Delivery Method:
Via Email
Food & Beverages

Recipient Name
Lee G. Ewing
Recipient Title
President and Owner
Sunny Creek Farm Inc.

520 Pinefield Drive
Tryon, NC 28782-7795
United States

Issuing Office:
Division of Human and Animal Food Operations East III

United States

Dear Mr. Ewing:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter 617664 dated February 2, 2022. We also verified your actions during an FDA inspection that ended September 15, 2022. Based on our evaluation and inspection, it appears that you have addressed the violation(s) 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.

For questions about this letter, please contact: Stephen J. Rabe, Compliance Officer at: orahafeast3firmresponses@fda.hhs.gov and Stephen.rabe@fda.hhs.gov or by telephone at: 513-322-0660:

Stephen J. Rabe
Compliance Officer

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