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  1. Warning Letters


GPC Medical Ltd. MARCS-CMS 536145 —

Medical Devices

Recipient Name
Vikas Narang
Recipient Title
GPC Medical Ltd.

GPC Square, M Block, DDA LSC
Vikas Puri 110018

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.

CAPT Raquel Peat, PhD, MPH, USPHS
OHT6: Office of Orthopedic Device
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

US Agent

Zachary Kelley
GPC Medical USA. Inc.
6060 N Central Expressway, Suite 560
Dallas, Texas US 75206

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