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Archive for Saturday, September 9, 2006

Red Cross fined $4.2M for blood violations

September 9, 2006

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— The government said Friday it was fining the American Red Cross a record $4.2 million for violating blood-safety laws.

The violations include failing to reject donors who had traveled to malarial areas and allowing blood and related products to be distributed without proper testing, said Margaret Glavin, the Food and Drug Administration's associate commissioner for regulatory affairs.

The FDA said it had no evidence of serious health consequences resulting from the violations.

The fine was the largest penalty ever assessed under terms of a 2003 court settlement that allows the large fines when the Red Cross violates FDA rules. Previously, the FDA had fined the Red Cross a total of $5.7 million.

The Red Cross provides nearly half the nation's blood supply, selling blood products to health facilities.

In a statement, the American Red Cross said its senior management "is committed to full compliance with the amended consent decree and all applicable federal regulations." It planned to respond to the FDA within 20 days.

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