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.

"FDA does not consider the current situation acceptable. It is not acceptable that the quality system has failed in this way and we will continue to work to make sure that the quality system is improved in its design and in its implementation, so these types of problems do not continue to occur," Glavin told reporters.

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.

The Red Cross is not aware of any health problems associated with the violations, spokesman Ryland Dodge said. The FDA said the nation’s blood supply remains safe.

The Red Cross will not use donated money to pay the fine, but instead will rely on operating funds, including revenue from the sales of blood products, Dodge said.

The fine stems from Red Cross recalls carried out between 2003 and 2005 that could have been prevented, the FDA said. The recalls involved about 12,000 units of blood and blood products. That number largely explains the size of the fine, Glavin said.

The 2003 agreement settled charges that the Red Cross had committed "persistent and serious violations" of federal blood safety rules dating back 17 years.

That settlement spelled out changes the Red Cross would have to make to comply with FDA rules, including improved training and record-keeping. The FDA is requiring the Red Cross to review its quality-control system, Glavin said.

"We will certainly continue to work with them to ensure there is full compliance," she said.

The amended consent decree also gave the FDA the authority to immediately fine the Red Cross for violations.


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