Sweet Ann Cake, Inc.

CLOSEOUT LETTER Sweet Ann Cake, Inc. MARCS-CMS 590155 — October 29, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: 23-HAFE4-WLCOL-02 Product: Food & Beverages Recipient: Recipient Name Mr. Francisco Aguayo Recipient Title President/Owner Sweet Ann Cake, Inc. Carretera 867, Km 7.8, Lote #3 Calle Bruno Cruz, Zona Industrial Toa Baja 00949 Puerto Rico f.aguayo@asmetalpr.com Issuing Office: Office of Human and Animal Food Operations East Division IV United States Dear Mr. Aguayo: The Food and Drug Administration has completed evaluation of your firm’s corrective actions as evidenced in our inspection conducted from February 8-21, 2023 (dates not all inclusive). This inspection served as a follow up to our Warning Letter, 20-HAFE4-WL-02 dated October 29, 2019. 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/ Pearl Lopina Director of Compliance Branch OHAFO, Division IV East Content current as of: 03/14/2023 Regulated Product(s) Food & Beverages