Global Medical Production Co., Ltd.

CLOSEOUT LETTER Global Medical Production Co., Ltd. MARCS-CMS 620544 — May 14, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Jeff Dai Recipient Title General Manager Global Medical Production Co., Ltd. 2nd Floor, No. 4 Building, No. 3288 West ZhougShan Road Xiuzhou Qu Jiaxing Shi Zhejiang Sheng , 314031 China Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Warning Letter Close-Out Dear Mr. Dai: 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 # 620544) dated November 16, 2021. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this Warning Letter. 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, Anton E. Dmitriev, Ph.D. Acting Director OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health cc: Michael Athey mathey@orangesurgical.com Content current as of: 05/18/2026 Regulated Product(s) Medical Devices