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  5. U.S. Dairy Unlimited, LLC - 590413 - 03/09/2020
  1. Warning Letters

CLOSEOUT LETTER

U.S. Dairy Unlimited, LLC MARCS-CMS 590413 —

Delivery Method:
UPS Next Day
Reference #:
20-HAFE4-WL-03
Recipient:
Recipient Name
Mr. Uri Zyman
Recipient Title
Owner
U.S. Dairy Unlimited, LLC

3301 NW 168th Street
Miami, FL 33056
United States

Issuing Office:
Office of Human and Animal Foods Division 4 East

United States

(787) 729-8500

Dear Mr. Zyman:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 20-HAFE4-WL-03 dated November 19, 2019. 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.

Kind regards,
/S/
Edwin Ramos
Director of Compliance Branch
OHAFO, Division IV East

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