Bush Brothers & Company

CLOSEOUT LETTER Bush Brothers & Company May 07, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Bush Brothers & Company United States Issuing Office: United States 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 Content current as of: 05/14/2018