Zyno Medical, LLC

CLOSEOUT LETTER Zyno Medical, LLC MARCS-CMS 507058 — December 03, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Chaoyoung Lee, Ph.D. Recipient Title President & CEO Zyno Medical, LLC Zyno Medical, LLC 177 Pine Street Natick , MA 01760-1029 United States cylee@careeverywhere.com Issuing Office: Center for Devices and Radiological Health One Montvale Avenue 4th floor Stoneham , MA 02180 United States Dear Dr. Lee: The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated December 5, 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/ Gina Brackett Director of Compliance Office of Medical Device and Radiological Health Division 1 U.S. Food and Drug Administration Content current as of: 12/04/2018