Contaminant Found in Heparin

Von Eschenbach said his agency plans to do more, but also said many products made in places such as China are tongue depressors or other items that do not need intense oversight.

The issue of foreign inspections of food and drugmakers in lightly regulated nations such as China and India has become a political as well as a safety issue, with several congressional committees conducting investigations and proposing legislation.

Last year, thousands of pets were reported to have fallen ill and died after eating pet food from China that was found to have been spiked with the chemical melamine, which was apparently added to make the food appear to be of higher quality. Authorities also recalled thousands of Chinese-made toys last year that were found to contain lead-based paint.

Regarding the contaminated heparin, Woodcock said: "We still don't know whether this inadvertently got into the supply or whether it was actually added. We can't tell you where the contamination originated."

Woodcock said that since December, the FDA has received 785 reports of serious allergic reactions linked to heparin, either in products supplied by Baxter or of unknown origin. She said the number of deaths associated with heparin had risen from four to 19, some occurring as far back as January 2007. In a statement, the company that supplies raw heparin to Baxter, Scientific Protein Laboratories LLC, said it had recalled all active ingredients from China that showed signs of possible contamination. The company also said it remained unclear whether the contaminant was the cause of the reactions.

"During the call with the media, FDA speculated that the source of the adverse events may be a contaminant. It is important to note that this theory is speculation at this point, and SPL is participating actively in working with the FDA to pursue this theory as well as others," the company said in a statement.

Baxter stopped distributing heparin early last month and last week recalled all remaining heparin products. The FDA stressed that the remaining supplies of heparin, made by APP Pharmaceuticals also from Chinese sources, did not show contamination.

Baxter's statement said it found the contaminant in samples from the Chinese plant and in samples processed at its Wisconsin factory from Chinese ingredients.

"These results suggest that the root cause may be associated with the crude heparin, sourced from China, or from the subsequent processing of that product before it reaches Baxter," the firm said.

The FDA said last week that a team of inspectors had found quality-control, waste-removal and machine-cleanliness issues at the Changzhou plant. But officials said they had not made any determination about whether those factors contributed to the contamination.