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  5. Bluegrass Proteins, Inc. - 533552 - 12/19/2018
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CLOSEOUT LETTER

Bluegrass Proteins, Inc. MARCS-CMS 533552 —


Recipient:
Recipient Name
Hoyt Huffman
Recipient Title
Chief Executive Officer
Bluegrass Proteins, Inc.
Puris Proteins, Inc.

1117 Cleveland Avenue
Glasgow, KY 42141
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

250 Marquette Avenue
Suite 600
Minneapolis, MN 55401
United States

(612) 334-4100

Dear Mr. Huffman:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 533552 dated October 26, 2017. 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.

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