U.S. Knew Last Year of Flu Vaccine Plant's Woes
By David Brown
Washington Post Staff Writer
Thursday, November 18, 2004; Page A01

The Food and Drug Administration found serious problems of bacterial contamination at an influenza vaccine plant in England in 2003, 16 months before British regulators effectively closed the site and impounded its flu shots because of fears they were tainted.

Those earlier problems were among many revelations in about 100 pages of documents released yesterday by a House committee looking into how the United States lost about half this winter's flu vaccine supply just as the season for giving the shots began.

The documents, which include FDA inspection reports, letters and e-mails, also revealed that the agency was nine months late in giving Chiron Corp., the owner of the plant, a detailed report of the problems it found and then rebuffed the company's efforts to learn more about what it could do to fix things. At the same time, FDA managers overruled its inspection team and made its fixes voluntary rather than mandatory.