Sucesores De Esmoris & Co., Inc.

CLOSEOUT LETTER Sucesores De Esmoris & Co., Inc. MARCS-CMS 518991 — January 02, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Mr. James Fox Recipient Title President Sucesores De Esmoris & Co., Inc. Sucesores De Esmoris & Co., Inc. 5 Comercio St Mayaguez , PR 00680 United States Issuing Office: United States 787-729-8500 Office of Office of Human and Animal Food Operations East Division IV Compliance Branch 466 Avenida Fernández Juncos San Juan, Puerto Rico 00901-3223 Tel: (787) 729-850 Office of Regulatory Affairs Office of Human and Animal Food Operations East Division IV Compliance Branch 466 Avenida Fernández Juncos San Juan, Puerto Rico 00901-3223 Tel: (787) 729-8500 January 2, 2018 18-HAFE4-WLCOL-02 VIA UNITED PARCEL SERVICE NEXT DAY - SIGNATURE REQUIRED Mr. James J. Fox, President Sucesores de Esmoris & Co., Inc. 5 Comercio St. Mayagüez, Puerto Rico 00680 Re: Warning Letter, 17-SJN-WL-05 dated 03/07/2017 Dear Mr. Fox: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter, 17-SJN-WL-05, dated 03/07/2017. 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/ Beira Montalvo Acting, Director of Compliance Branch OHAFO East Division IV Content current as of: 01/04/2018