Chinese Syringe Manufacturer Receives Second FDA Warning

Regarding plastic syringes manufactured in China, the FDA announced that it has written two further warning letters.

Following an examination of its Chinese factory, Jiangsu Shenli Medical Production was sent a second FDA caution letter, following the one that was sent in March. In order to prevent enteral syringes from entering the country, the FDA increased the import alert on the business.

Following the visit, Jiangsu Caina received a warning notice on July 18 detailing the breaches of the quality system rule. The manufacture of Monoject syringes, the brand name of Cardinal Health syringes that started the inquiry into Chinese goods last year, is the subject of several FDA findings.

The FDA stated: “Based on FDA’s inspectional findings, it appears that your firm’s failure to thoroughly analyze and investigate complaint data for these syringes may have contributed to a delay in recognition that the risk of incompatibility applied to additional sizes of Cardinal Health Monoject syringes.”