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FDA targets Red Cross for blood violations
WASHINGTON (CNN) -- The Food and Drug Administrations asked a federal judge Thursday to hold the American Red Cross in contempt of court for repeated safety violations in its blood collection program. "FDA is acting today to ensure that the American Red Cross takes much more seriously its role as guardian of the safety of the nation's blood supply, which is essential to the public health," said the FDA's Acting Principal Deputy Commissioner Bernard Schwetz. Despite a promise made by the Red Cross in a 1993 consent decree to make "substantial improvements" in the quality control of its blood program, inspections over the past two years have "revealed persistent and serious violations of blood safety rules," the FDA said in a statement. "Unfortunately to date ARC has exhibited a corporate culture that has been willing to tolerate an unacceptably low level of quality assurance and a lack of concern for the public it is supposed to serve," Schwetz said. Red Cross officials have yet to return calls from CNN seeking comment. FDA inspectors said they found several violations including incorrect labeling and release of potentially contaminated blood, a lack of adequate quarantine and inventory controls and inadequate donor registration controls. The FDA wants the court to grant it the power to levy fines of $10,000 a day as well as for each future safety violation inspectors discover, FDA spokeswoman Monica Revelle said. Despite the problems, Schwetz emphasized the overall safety of the blood program and urged those who need blood transfusions to receive them. He also reiterated the safety of giving blood and encouraged people to continue to take part in this "safe and unselfish act." "The health of millions of Americans depends on it," he said. |
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