Miami Fat Supply, Inc

CLOSEOUT LETTER Miami Fat Supply, Inc MARCS-CMS 485740 — January 19, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Miami Fat Supply, Inc United States Issuing Office: United States Florida District Office 555 Winderley Place #200 Maitland, FL 32751 Telephone: (407) 475-4700 VIA ELECTRONIC MAIL mark@miamifatsupply.com January 19, 2018 Mr. D. Mark Jordan, President Miami Fat Supply, Inc. 1510 Max Hooks Road, #F Groveland, Florida 34736 U.S.A. RE: Warning Letter Close-Out Letter – FEI 3008872140 CMS Case ID: 485740, CMS WA ID: 182270 Dear Mr. Jordan: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter FLA-16-12, dated March 17, 2016. Based on our evaluation, it appears that you have addressed the violation(s) 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/ Kathleen M. Sinninger Acting Program Division Director Division of Medical Devices and Radiological Health Operations II Central Content current as of: 01/23/2018