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  5. Universal Pure, LLC - 455150 - 05/16/2019
  1. Warning Letters

CLOSEOUT LETTER

Universal Pure, LLC MARCS-CMS 455150 —

Delivery Method:
UPS Overnight
Reference #:
2015-DAL-WL-28
Product:
Food & Beverages

Recipient:
Recipient Name
Jeffrey L. Barnard
Recipient Title
President
Universal Pure, LLC
Universal Pasteurization, LLC

1601 Pioneers Blvd.
Lincoln, NE 68502
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

4040 North Central Expressway
Suite 300
Dallas, TX 75204
United States


Dear Mr. Barnard,

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (Ref: 2015-DAL-WL-28) dated August 24, 2015, issued following inspection of your facility located at 777 Freeport Pkwy, Ste. 130, Coppell, TX 75019. 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 Hensley
Director of Compliance
Office of Human and Animal Food, WD3