FDA testing all supplies of blood thinner

Baxter bought the main Heparin ingredient from Scientific Protein Laboratories, a Wisconsin company that co-owned the Changzhou plant in eastern China. The Changzhou plant is no longer allowed to ship products to the U.S., Woodcock said, and FDA inspectors have been ordered to stop all other Heparin imports to make sure they have undergone the sophisticated testing for the contaminant.

Meanwhile, the five leading makers of Heparin and its key ingredient have committed to testing all of their supplies, said Steve Silverman, an FDA compliance official.

Critics have attacked the FDA for failing to inspect the Changzhou plant, as well as the farms, workshops and middlemen that supplied it with the pig intestines that are crushed and then purified to make the main Heparin ingredient. Critics say the FDA and industry need to do a better job policing the quality of drugs throughout their overseas supply chains.

In addition to visiting the Changzhou facility, the FDA has spoken with some of its suppliers and has discussed probing the rest of the supply chain with Chinese authorities, agency officials said.

"We are not simply relying on information from our Chinese counterparts," Silverman said. "We are engaged in an active investigation."

As part of its inspection of the Changzhou plant, Baxter confirmed that the facility assured the integrity of its suppliers, said Deborah Spak, a company spokeswoman. Baxter has sought to visit the Changzhou plant's suppliers, Spak said, "but we have not been able to get in there, and, quite honestly, that would be voluntary on their part. We are not their customer."

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