U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Jiangsu JDC Medical Devices Co., Ltd. - 598340 - 05/20/2021
  1. Warning Letters

CLOSEOUT LETTER

Jiangsu JDC Medical Devices Co., Ltd. MARCS-CMS 598340 —

Product:
Medical Devices
Recipient:
Recipient Name
Qing (Michael) Yang
Jiangsu JDC Medical Devices Co., Ltd.

No. 8, Jing 8 Road, Lianyun Development Zone
Lianyungang, Jiangsu
222047
China

Issuing Office:
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, Office of Product Evaluation and Quality

United States

Dear Mr. Yang:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 598340, dated December 16, 2019). Based on our evaluation, it appears that you have addressed the violation(s) 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/
Courtney H. Lias, Ph.D.
Acting Office Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

CC:
Fiona Chan
SUNGO Technical Service Inc.
6050 W. Eastwood Avenue, Apt. 201
Chicago, Illinois 60630

Back to Top