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  5. T & S Dairy - 604555 - 05/13/2020
  1. Warning Letters

CLOSEOUT LETTER

T & S Dairy MARCS-CMS 604555 —

Delivery Method:
UPS Overnight
Product:
Drugs
Recipient:
Recipient Name
Erna De Boer
Recipient Title
Owner
T & S Dairy

19008 FM 3079
Chandler, TX 75758-7667
United States

Issuing Office:
Office of Human and Animal Food Operations West Division 3

United States

Dear Mrs. De Boer,

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated April 14, 2020, issued following inspection of your facility located at Private Road 116, Box 7573, Winnsboro, TX 75494. 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 E. Havranek
Director of Compliance
Office of Human and Animal Food, WD3

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