GS Medical Packaging Inc.

CLOSEOUT LETTER GS Medical Packaging Inc. MARCS-CMS 395298 — October 19, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name John Sherlock Recipient Title President GS Medical Packaging Inc. 82 Akron Road Unit # 2 Etobicoke ON Canada Issuing Office: Center for Devices and Radiological Health 10903 New Hampshire Avenue Silver Spring , MD 20993-0002 United States Dear Mr. Sherlock: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective and preventive actions in response to our Warning Letter (CMS# 395298) dated June 12, 2013. Based on our evaluation, it appears that your firm has 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. Sincerely yours, /S/ For Ann M. Ferriter Director Division of Analysis and Program Operations Office of Compliance Center for Devices and Radiological Health cc: Alan Schwarts mdi Consultant, Inc. 55 Northern Blvd ste 200 Great Neck, NY 11021 Content current as of: 10/30/2018