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CLOSEOUT LETTER

Bluegrass Dairy and Food Inc 05/05/2015

Bluegrass Dairy and Food Inc - Close Out Letter 5/5/15


Bluegrass Dairy and Food Inc

  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 Food and Drug Administration
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-30977
Telephone: (513) 679-2700
           FAX: (513) 679-2761 

May 5, 2015

Mr. Billy Joe Williams, CEO
Bluegrass Dairy and Food, Inc.
1117 Cleveland Ave.
Glasgow, KY 42141-1011

Dear Mr. Williams:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CIN-14-414421-09 dated February 12, 2014. 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/

Toniette K. Williams
Director, Compliance Branch
Cincinnati District


Cc:

John Wilcha, Chairman
Bluegrass Holdco, Inc.
2187 Atlantic St.
Stamford, CT 06902