CLOSEOUT LETTER
Global Medical Production Co., Ltd. MARCS-CMS 620544 —
- Product:
- Medical Devices
- Recipient:
-
Recipient NameJeff Dai
-
Recipient TitleGeneral 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
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