Roorda Dairy

CLOSEOUT LETTER Roorda Dairy MARCS-CMS 556590 — April 08, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Product: Animal & Veterinary Recipient: Recipient Name Larry Roorda, Scott Roorda, Lance Roorda Recipient Title Co-Owners Roorda Dairy 5128 460th St. Paullina , IA 51046 United States Issuing Office: Center for Veterinary Medicine 8050 Marshall Drive Suite 205 Lenexa , KS 66214-1524 United States 913-495-5100 Dear Messrs. Larry Roorda, Scott Roorda and Lance Roorda: The Food and Drug Administration has completed an evaluation of Roorda Dairy, LLC corrective actions in response to our Warning Letter (CMS case #: 556590) on July 9, 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: 04/12/2019 Regulated Product(s) Animal & Veterinary