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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Crown O' Maine Organic Cooperative - Close Out Letter 1/29/13

  

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) 587-7500
FAX: (781) 587-7556

January 29, 2013


Leah Cook, Director of Operations
Crown O'Maine Organic Cooperative
P.O. Box 4
Vassalboro, Maine 04989


Dear Ms. Cook:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [CMS 228454, December 6, 2011]. 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.


Sincerely,

/S/

Amber Wardwell
Director Compliance Branch
New England District