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CLOSEOUT LETTER

Bush Brothers & Company


Recipient:
Bush Brothers & Company


United States

Issuing Office:

United States


 

  

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Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772 

May 7, 2018

Michael T. Smith, Director of Operations
Bush Brothers and Company
3304 Chestnut Hill Road
Dandridge, Tennessee 37725-2669

Dear Mr. Smith:

The Food and Drug Administration (FDA) completed an evaluation of your firm’s corrective actions in response to our Warning Letter No. 535494. Based on our evaluation, it appears 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/

Kimberly A. Dutzek
Compliance Officer, Division V
Office of Human and Animal Foods Operations-East