Liqun Yang
General Manager
Jiangsu Shenli Medical Production Co., Ltd.
No. 20 Changzheng Road
Zhengluzhen
Wujin Qu
Changzhou Shi
Jiangsu Sheng ,FEI 3003902757Issued Mar 18, 2024Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3003902757.
Violations2
Issue DateMar 18, 2024
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
Jiangsu Shenli Medical Production Co., Ltd.
Location
Liqun Yang
General Manager
Jiangsu Shenli Medical Production Co., Ltd.
No. 20 Changzheng Road
Zhengluzhen
Wujin Qu
Changzhou Shi
Jiangsu Sheng ,
FEI Number
3003902757
Country
China
Issue Date
March 18, 2024
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Open
Summary
Jiangsu Shenli Medical Production Co., Ltd. was cited for marketing multiple piston syringe models in the United States without obtaining the required FDA marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act. The warning covered approximately 50 syringe configurations across various sizes (1mL to 60mL) and formulations, including models with different needle gauges and pre-filled solutions such as saline, lidocaine, heparin, and nitroglycerin. The company's unlicensed distribution of these medical devices represented a significant compliance failure in the regulatory authorization requirements for Class II and Class III medical devices.
Jiangsu Shenli Medical Production Co., Ltd. FDA Warning Letter, March 18, 2024
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