FDA never inspected Chinese maker of heparin

U.S. regulators have never inspected the Chinese plant that makes Baxter International’s heparin, regulators disclosed a day after Baxter halted sales of some versions after four patients died and hundreds became ill.

“Preparations are being made to perform an inspection as soon as possible,” Food and Drug Administration spokeswoman Karen Riley said in an email.

On Tuesday, the Food and Drug Administration reported that it received about 350 reports of health problems associated with Baxter’s injectable heparin, a blood thinner, since the end of 2007.

Baxter, which makes about half of all multiple-dose vials of heparin sold in the United States, said it has inspected the facility within the last six months. The plant is owned by a U.S.-based company, and Baxter plans another inspection in the near future.

Baxter spokeswoman Erin Gardiner said that company, which it would not name for proprietary reasons, has been making heparin for more than 30 years.

Heparin, which has been in widespread clinical use since the 1930s, is administered in operating rooms and other critical care areas to prevent blood clots and is crucial in hemodialysis and heart surgery. Millions of patients each year receive the product intravenously.

The drug generates about $29 million in annual revenue for Baxter, less than 1 percent of the company’s total revenue, Gardiner said.