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  5. DSM Nutritional Products, LLC - 578300 - 06/03/2020
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CLOSEOUT LETTER

DSM Nutritional Products, LLC MARCS-CMS 578300 —

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

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