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PA Constans - Minnesota Emu MARCS-CMS 543014 —

Recipient Name
Patricia A. Constans
Recipient Title
PA Constans - Minnesota Emu

24200 Fairwood Lane
Nevis, MN 56467-4218
United States

Issuing Office:
Center for Food Safefty and Applied Nutrition

United States

(812) 334-4100

Dear Ms. Constans:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 543014 dated February 23, 2018. Based on our evaluation, 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.

Demetria L. Lueneburg
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations

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