Gonzalez and Nietos, LLC

CLOSEOUT LETTER Gonzalez and Nietos, LLC MARCS-CMS 561490 — December 28, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: 19-HAFE4-WL-03 Product: Food & Beverages Recipient: Recipient Name Mr. Andrew M. Gonzalez Recipient Title President Gonzalez and Nietos, LLC 3320 NW 73rd St Miami , FL 33147-5822 United States agonzaleznietos@yahoo.com Issuing Office: San Juan District Office United States Dear Mr. Andrew M. Gonzalez, President: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our amended Warning Letter, 19-HAFE4-WL-03 dated November 29, 2018. 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/ Laura Kennedy Acting Director of Compliance Branch Office of Human and Animal Food Operations Division IV East Content current as of: 01/04/2022 Regulated Product(s) Food & Beverages