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Calwood Nutritionals, LLC. MARCS-CMS 482185 —

Food & Beverages

Recipient Name
Gary J. Calton
Recipient Title
Managing Member
Calwood Nutritionals, LLC.

1228 Hay Meadow Ln.
Sykesville, MD 21784-5438
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

6000 Metro Drive
Suite 101
Baltimore, MD 21215
United States

410- 779-5455

Dear Mr. Calton,

On December 12, 2018, The Food and Drug Administration completed an evaluation of your firm’s corrective actions in response to our Warning Letter (#482185), dated February 2, 2016. Based on our evaluation, 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.

CDR Rochelle B. Young, RPh, MSA
Human and Animal Food Division 2 East
Compliance Officer

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