By the time St. Louis Children's Hospital called in its infectious-disease specialist Jan. 4 to diagnose a mysterious spike in allergic reactions to kidney dialysis, it was clear there was a major problem. Three patients had become ill after taking the blood-thinning drug heparin. One had developed the same reaction during a dialysis treatment in November. Minutes after dialysis needles punctured their veins, the boys' lips and eyelids swelled. Their blood pressure dropped, and their heartbeats raced at dangerous levels. When infectious-disease specialist Dr. Alexis Elward homed in on the problem -- putting high on her list the drug made by Baxter International Inc. of Deerfield -- she became the first doctor to alert the Centers for Disease Control and Prevention. It wasn't until late in February, though, that Elward and others learned that no U.S. or Chinese government inspectors had visited the Chinese plant that produced the drug now linked to more than 400 illnesses and as many as 21 deaths across the U.S.

The plant isn't being overlooked anymore. Last week, a team of Food and Drug Administration inspectors visited the Chinese plant owned by Baxter supplier Scientific Protein Laboratories of Waunakee, Wis. There they found evidence of lax hygiene and safety standards. According to the inspection report, testing procedures at the plant were inadequate. In some cases, records of testing were missing. And for some batches of the product, there was no way to trace where the plant obtained its raw material, which is scraped from the mucous lining of pig intestines. One of the more worrisome findings: When heparin produced at the plant did not pass its quality testing, plant workers failed to diagnose what caused the failures. On two lots that failed tests, plant workers simply -- but incorrectly -- dismissed the results as "outliers." Now a congressional committee is asking whether the FDA's lapse in allowing a plant it never inspected to export to the U.S. is part of a larger problem of poor oversight and a shortage of resources at the agency. And Baxter itself is scurrying to learn what went wrong.

A close look at the FDA's resources and inspection record paints a picture of an agency struggling to keep pace. Although its officials insist the agency inspects every foreign plant sending medical products to the U.S., the agency's own data make it appear unlikely. An FDA-appointed commission that studied the agency's inspection record last fall found the FDA is short of financial resources, has cut personnel, has rickety data management systems and is struggling to meet its oversight obligations. "Millions of FDA-regulated products are imported into the country each year from foreign facilities that have never been inspected by FDA and, with current appropriations, never will be," according to a report in November by the FDA Science Board's subcommittee on science and technology. The head of the FDA study group, in an interview, held out little hope the FDA is coming to grips with its challenges. The heparin case is a warning signal, said Gail Cassell, vice president of scientific affairs at drug giant Eli Lilly & Co. "Unless the deficiencies can be addressed rather urgently, this is not the last such situation," said Cassell. "We will have more of them."

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