Sarita's Tortilla Factory, Inc

CLOSEOUT LETTER Sarita's Tortilla Factory, Inc MARCS-CMS 617384 — November 30, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Overnight Product: Food & Beverages Recipient: Recipient Name Maria X. Villarreal Recipient Title CEO and Co-Owner Sarita's Tortilla Factory, Inc 2505 El Indio Hwy Eagle Pass , TX 78852-5537 United States Issuing Office: Office of Human and Animal Food Operations West Division 3 United States Dear Ms. Villarreal, The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated November 22, 2021, issued following inspection of your facility located at 2505 El Indio Hwy., Eagle Pass, TX 78852-5537. 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/ René R. Ramirez Compliance Officer Office of Human and Animal Foods, West Division 3 Content current as of: 12/07/2022 Regulated Product(s) Food & Beverages