WASHINGTON - U.S. inspectors found some mostly procedural problems at a Chinese factory that supplied the main ingredient for the recalled blood thinner heparin, but said yesterday they can't tell what is to blame for serious side effects.
"We're still considering all possibilities," said Deborah Autor, Food and Drug Administration compliance chief. "We have not ruled anything out at this point."
Baxter International halted production earlier this month after the blood thinner was linked to four deaths and hundreds of reports of allergic-type reactions, including vomiting, nausea, and difficulty breathing.
The FDA has completed an inspection of the Chinese factory, Changzhou SPL, that supplied the active ingredient, and yesterday posted its draft inspection findings on its Web site. The FDA is under intense scrutiny because it admitted that an agency mix-up meant the Chinese factory never had been inspected before the heparin started being sold.
Heparin, used to prevent blood clotting, generally is made from pig intestines. In China and other countries, tracing the animal source can be difficult.
The FDA stressed that inspectors' initial findings must be scrutinized further. China isn't the probe's sole focus; the FDA is inspecting U.S. facilities.
The FDA said it has 448 reports of possible problems from any manufacturer, but the agency thinks that those are associated with the problematic Baxter product number 215.
Baxter hadn't recalled all the problematic vials because the FDA feared triggering a shortage. Baxter took that step yesterday after the FDA verified a second
U.S. supplier will fill the gap.
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