Flayco Products, Inc.

CLOSEOUT LETTER Flayco Products, Inc. MARCS-CMS 534460 — December 10, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Reference #: 20-HAFE4-WLCOL-01 Product: Food & Beverages Recipient: Recipient Name Mr. Jorge Astorquiza Sr. Recipient Title President Flayco Products, Inc. 4823 N. Hale Ave. Tampa , FL 33614-6517 United States Issuing Office: Office of Human and Animal Feed Operations East Division IV United States (787) 729-8500 Dear Mr. Astorquiza: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 17-OHAFOEDIV4-WL-08 dated August 18, 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/ Edwin Ramos Director of Compliance Branch Office of Human and Animal Feed Operations, East Division IV Content current as of: 12/19/2019 Regulated Product(s) Food & Beverages