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CLOSEOUT LETTER

Montes Tortilla Factory MARCS-CMS 541060 —

Delivery Method:
VIA UPS
Product:
Food & Beverages

Recipient:
Recipient Name
Dahlia Rodriguez
Recipient Title
Owner
Montes Tortilla Factory

7536 North FM 88
Weslaco, TX 78599
United States

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

United States

214-253-5200

Dear Ms. Rodriguez:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case 541060) issued on November 14, 2017. 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/
Casey Hamblin
Recall Coordinator/Compliance Officer
Office of Human and Animal Food-West Div. 3