DSM Nutritional Products, LLC

CLOSEOUT LETTER DSM Nutritional Products, LLC MARCS-CMS 578300 — June 03, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Overnight Product: Animal & Veterinary Recipient: Recipient Name Chris Goppelsroeder Recipient Title President DSM Nutritional Products, LLC 45 Waterview Blvd. Parsippany , NJ 07054 United States Issuing Office: Human & Animal Food Operations, West Division 3 United States Dear Mr. Goppelsroeder: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS 578300 dated October 11, 2019) issued following an inspection of your vitamin and mineral premix animal food manufacturing facility located at 5101 Rondo Dr., Fort Worth, TX 76106. Based on our evaluation, it appears that 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/ Jessica E. Havranek Director, Compliance Branch Human & Animal Food Operations, WD3 Cc: Stephen J. Gristina, Director of Premix Operations – North America DSM Nutritional Products, North America 45 Waterview Blvd. Parsippany, NJ 07054 Lance Collard, Plant Manager DSM Nutritional Products, LLC 5101 Rondo Drive Fort Worth, TX 76106 Office of Texas State Chemists Dr. Timothy Herrman 445 Agronomy Road College Station, TX 77843 Content current as of: 06/12/2020 Regulated Product(s) Animal & Veterinary