Perla Del Sur Foods L.L.C.

CLOSEOUT LETTER Perla Del Sur Foods L.L.C. MARCS-CMS 562174 — January 31, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Reference #: 20-HAFE4-WLCOL-02 Product: Food & Beverages Recipient: Recipient Name Mr. Ernesto Vázquez Borrero Recipient Title President Perla Del Sur Foods L.L.C. Don Julio Tropical Food LLC Ext. La Guadalupe Calle Guadalupe # 62 Ponce , PR 00730 United States Issuing Office: Office of Human and Animal Food Operations Division IV East United States (787) 729-8500 Dear Mr. Vázquez Borrero: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to 18-HAFE4-WL-04 dated August 15, 2018. During the current establishment inspection, we were informed that our firm is no longer operational. 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 Office of Human and Animal Feed Operations, East Division IV Content current as of: 04/28/2020 Regulated Product(s) Food & Beverages