GPC Medical Ltd.

CLOSEOUT LETTER GPC Medical Ltd. MARCS-CMS 536145 — May 19, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Vikas Narang Recipient Title Owner GPC Medical Ltd. GPC Square, M Block, DDA LSC Vikas Puri 110018 Delhi India Issuing Office: Center for Devices and Radiological Health United States Dear Mr. Vikas Narang: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 536145, dated October 20, 2017). Based on our evaluation, it appears that you have 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, /S/ CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Device Office of Product Evaluation and Quality Center for Devices and Radiological Health CC: US Agent Zachary Kelley GPC Medical USA. Inc. 6060 N Central Expressway, Suite 560 Dallas, Texas US 75206 info@gpcmedicalusa.com Content current as of: 05/24/2021 Regulated Product(s) Medical Devices