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Florida: Blood Bank Received Warning Letters from FDA

July 19, 2002

Three times in the late 1990s the Food and Drug Administration (FDA) sent warning letters to Florida Blood Services (FBS) about improper procedures, including two letters criticizing its handling of blood being tested for HIV. But officials with the blood bank, which collects about 200,000 pints a year from 100,000 donors, said Thursday the problems have been corrected. They said the agency is vigilant about searching for impurities in the plasma, red blood cells and platelets it sends to 30 hospitals in Pinellas, Hillsborough and Pasco counties.

"I think we do an excellent job," said Don Doddridge, CEO of FBS. He said his employees are dedicated and "they don't want to let a bad product out of here." The FDA said the agency did not perform HIV testing properly in one case. In another, it did not properly document how it disposed of HIV-infected blood. In a third, the FDA said a syphilis test was performed incorrectly. Doddridge stressed, however, that FBS did not send out tainted blood in any of those cases. The FDA routinely inspects blood centers to make sure they are properly testing for infected blood and documenting how they do it.

FDA spokesperson Lawrence Bachorik said "a warning letter from the FDA is a serious bit of business." But he added the FDA can take more severe regulatory actions against agencies with more severe problems. "If the FDA thought they were an imminent threat to the public health they could revoke the license," and do so quickly, Bachorik said. Blood banks that fail to correct their problems also can be required to sign legally binding consent decrees that require them to make improvements, with oversight from a court, he said. The American Red Cross, for example, has operated under a consent decree since 1993.

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Excerpted from:
St. Petersburg Times
07.19.02; Curtis Krueger

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