Agape III

CLOSEOUT LETTER Agape III MARCS-CMS 483384 — October 18, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Charles Crissey Recipient Title Owner Agape III Agape III Alligator Bay Marina, Way & Bains Rd Alligator Bay , Long Island Bahamas crisseycharles@gmail.com Issuing Office: United States Dear Mr. Crissey: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 483384, issued December 10, 2015. Based on our evaluation, it appears you have addressed the violations contained in the 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/ Maria G. Corpuz, Team Leader Food Adulteration and Assessment Branch Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 10/30/2018