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Sweet Ann Cake, Inc. MARCS-CMS 590155 —

Delivery Method:
VIA Electronic Mail
Reference #:
Food & Beverages

Recipient Name
Mr. Francisco Aguayo
Recipient Title
Sweet Ann Cake, Inc.

Carretera 867, Km 7.8, Lote #3
Calle Bruno Cruz, Zona Industrial
Toa Baja 00949
Puerto Rico

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.

Pearl Lopina
Director of Compliance Branch
OHAFO, Division IV East

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