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# 2 More Warning Letters for Chinese Plastic Syringes
- URL: https://www.fdaweb.com/2-more-warning-letters-for-chinese-plastic-syringes/
- Published: 2024-07-18T12:00:00.000Z
- Updated: 2026-09-14T14:35:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157386

FDA says it has issued two additional Warning Letters as part of its ongoing evaluation of plastic syringes made in China for potential medical device failures. Warning Letters were sent to Jiangsu Shenli Medical Production Co., Ltd. for quality system violations for syringe products, and to Jiangsu Caina Medical Co., Ltd. for quality system violations, an FDA [update](https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication?utm%5Fmedium=email&utm%5Fsource=govdelivery) says.

The agency says its recommendations have been updated to include that users should also immediately transition away from using enteral syringes manufactured by Jiangsu Shenli unless use of the syringes is absolutely necessary until the transition to syringes manufactured by a different manufacturer can be completed.

The Jiangsu Shenli [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jiangsu-shenli-medical-production-co-ltd-687035-07182024?ref=fdaweb.com) followed a 3/25-3/29 inspection of the firm’s facility in Jiangsu, China, and contains these specific violations:

- failure to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met; and
- failure to establish and maintain device master records.

FDA says the adequacy of the firm’s responses to the inspection observations cannot be determined. It says the agency has taken steps to refuse entry through detention without physical examination.

The Jiangsu Caina [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jiangsu-caina-medical-co-ltd-687033-07182024?ref=fdaweb.com) followed a 3/11-3/23 inspection at the firm’s facility in Jiangsu, China, and lists these violations:

- failure to adequately establish and maintain procedures for corrective and preventive action; and
- failure to establish and maintain procedures for validating the device design, including risk analysis.

The letter says the firm’s responses to the inspection observations were not adequate. It also says the company failed to submit a report to FDA no later than 30 days after the day it received or otherwise became aware of information, from any source, that reasonably suggested that a device that it markets had malfunctioned and that the device or a similar one would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Jiangsu Caina products are being detained without physical examination, FDA says.