Organ Recovery Systems, Inc.

CLOSEOUT LETTER Organ Recovery Systems, Inc. MARCS-CMS 519572 — November 28, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name David Kravitz Recipient Title President and CEO Organ Recovery Systems, Inc. Organ Recovery Systems, Inc. One Pierce Place Suite 475W Itasca , IL 60143 United States Issuing Office: Center for Devices and Radiological Health 550 W. Jackson Blvd. 15th Floor Chicago , IL 60661 United States Dear Mr. Kravitz: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CHI-07-17 dated April 20, 2017. 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/ Blake Bevill, MS Program Division Director Office of Medical Device and Radiological Health OMDRHO Division 2 - Central CC: Pedro Juan Pardo, Director of Regulatory and Clinical Affairs : Christopher M. Hill, Director of Quality Assurance Content current as of: 12/04/2018