Baxter tests point to Chinese problem

Baxter is zeroing in on the possibility that a supplier's uninspected Chinese plant [1]faltered while processing the active ingredient in its heparin drug, the Los Angeles Times reports. Testing found irregularities in samples processed in China; the same irregularities were absent from samples from the same supplier's Wisconsin plant. When the Times sent a reporter to the Chinese plant, guards turned him away, but an unrelated heparin-making facility nearby let him in to see its thumbprint-access security system and other safeguards.

You'll recall that Baxter stopped making its multiuse vials of heparin [2] after the FDA received reports of hundreds of adverse reactions to the med. The company also recalled some 32 million vials. Much of the active ingredient in the drug came from a plant in China never inspected by Chinese or U.S. regulators.

- read the LA Times article [3]

Related Articles:
FDA inspected wrong Chinese plant. Report [1]
Congressman: FDA chief should resign. Report [4]
Chinese plant linked to recalled heparin. Report [5]
Baxter stops making multidose heparin. Report [2]
Baxter recalls heparin on adverse events. Report [6]