Thornton Enterprises DBA The Donut Stop

CLOSEOUT LETTER Thornton Enterprises DBA The Donut Stop MARCS-CMS 544523 — June 26, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Product: Food & Beverages Recipient: Recipient Name Cole and Heather Thornton Recipient Title Owners Thornton Enterprises DBA The Donut Stop 606 W. Sheridan Ave. Shenandoah , IA 51601 United States Issuing Office: Division of Human and Animal Food Operations West II 8050 Marshall Drive, Suite 205 Lenexa , KS 66214-1524 United States June 26, 2019 DELIVERY VIA UPS WARNING LETTER CLOSE-OUT LETTER Cole and Heather Thornton, Owners Thornton Enterprises dba The Donut Stop 606 W. Sheridan Ave. Shenandoah, IA 51601 Dear Mr. & Mrs. Thornton: The Food and Drug Administration has completed an evaluation of Thornton Enterprises dba The Donut Shop corrective actions in response to our Warning Letter (CMS case #: 544523) on March 19, 2018. 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/ Miguel A. Hernandez Director, Compliance Office of Human and Animal Food – Division II West Content current as of: 06/27/2019 Regulated Product(s) Food & Beverages