Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

FDA extends import alert to block all plastic syringes from Chinese manufacturer

The FDA enforces import alerts to enable the detention of products without physical examination, typically when a company is found to violate good manufacturing practices or when a foreign regulator alerts the FDA of similar issues. In March, the agency issued a warning letter to Jiangsu Shenli following an inspection of Medline Industries, a distributor of its plastic syringes in the U.S. FDA inspectors alleged that Medline provided Jiangsu Shenli with devices possessing significantly different technological characteristics than those authorized in the Chinese company’s 510(k) clearance.

Consequently, the FDA advised healthcare providers to cease using unauthorized plastic syringes from Jiangsu Shenli unless necessary, as the company's only authorized device is a 5 mL luer lock syringe. Subsequently, the FDA issued an import alert against Jiangsu Shenli, focusing on the unauthorized devices mentioned in the warning letter. This update ensures that import alerts now cover all products from both Chinese companies under investigation.