Distribuidora La Jugosita, Inc.

CLOSEOUT LETTER Distribuidora La Jugosita, Inc. MARCS-CMS 532714 — April 30, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: 17-OHAFOE4-WL-07 Product: Food & Beverages Recipient: Recipient Name Mr. William Rodriquez Recipient Title President Distribuidora La Jugosita, Inc. Carretera #1, Km. 50.9 Cidra , PR 00739 United States info@lajugosita.com Issuing Office: San Juan District Office United States (787) 729-8500 Dear Mr. Rodriguez: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 17-OHAFOE4-WL-07 dated August 17, 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. Kind regards, /S/ Marilyn Santiago Acting Director, Compliance Branch Office of Human and Animal Food Operations Division IV East Content current as of: 05/10/2021 Regulated Product(s) Food & Beverages