CLOSEOUT LETTER
Jiangsu Caina Medical Co. Ltd. MARCS-CMS 687033 —
- Delivery Method:
- VIA Electronic Mail
- Product:
- Medical Devices
- Recipient:
-
Recipient NameJun Lu
-
Recipient TitleBoard Chairman
- Jiangsu Caina Medical Co. Ltd.
No. 23 Huanxi Road
Zhutang Town
Jiangyin City
Jiangsu Sheng,
China
- Issuing Office:
- Center for Devices and Radiological Health
United States
United States
Dear Mr. Jun Lu:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS#687033 issued July 18, 2024. 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/
Michael J. Hoffmann
Director
Office of Health Technologies 3
Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC: DJ Fang
us-agent@purefda.com