T & S Dairy

CLOSEOUT LETTER T & S Dairy MARCS-CMS 604555 — May 13, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Overnight Product: Drugs Recipient: Recipient Name Erna De Boer Recipient Title Owner T & S Dairy 19008 FM 3079 Chandler , TX 75758-7667 United States Issuing Office: Office of Human and Animal Food Operations West Division 3 United States Dear Mrs. De Boer, The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated April 14, 2020, issued following inspection of your facility located at Private Road 116, Box 7573, Winnsboro, TX 75494. 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. If you choose to reestablish or sell your operations, 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/ Jessica E. Havranek Director of Compliance Office of Human and Animal Food, WD3 Content current as of: 05/21/2020 Regulated Product(s) Drugs