Dive Brief:
- The Food and Drug Administration said Thursday it has issued import alerts against two more Chinese manufacturers of plastic syringes.
- Officials moved to stop plastic syringes made by Zhejiang Longde Pharmaceutical and Shanghai Kindly Enterprise Development Group from entering the U.S. after finding quality system failings.
- The FDA has asked healthcare providers to immediately transition away from using plastic syringes made by the two companies unless absolutely necessary.
Dive Insight:
The latest import alerts are part of an investigation the FDA began in November. The agency started testing devices made in China and advised healthcare providers to consider switching to products manufactured in other countries after receiving reports about quality problems that could cause plastic syringes to leak and break.
In March, the FDA strengthened its recommendations, asking U.S. suppliers, consumers and healthcare organizations to immediately transition away from certain devices. The agency also issued three warning letters and an import alert that month. A second import alert and fourth warning letter followed in April.
After the latest action, four Chinese manufacturers of plastic syringes are subject to import alerts. The FDA uses the alerts, which allow products to be detained without physical examination, to stop imports of devices from companies with manufacturing problems.
The agency issued the latest alerts because the two companies were “not meeting device quality system requirements.”
The FDA is continuing to evaluate problems with syringes made in China. The agency also sent warning letters to Jiangsu Shenli Medical Production, Medline Industries, Sol-Millennium Medical and Cardinal Health. Sol-Millennium is recalling affected products.
Against that backdrop, President Joe Biden announced on Tuesday the U.S. will increase the tariff rate on Chinese syringes and needles from zero to 50%. The increase is part of a set of tariff hikes that will also raise the rates on rubber gloves and certain respirators and face masks.