WASHINGTON – The U.S. government said Friday it was fining the American Red Cross $4.2 million for violating blood-safety laws.
The violations include failing to ask appropriate questions of potential donors and not following test procedures, said the Food and Drug Administration. The FDA said it had no evidence of serious health consequences resulting from the violations.
The fine was the largest single penalty assessed so far 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.
In a statement, the American Red Cross said its senior management takes the fine seriously and "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 Red Cross provides nearly half the U.S. blood supply, selling blood products to health facilities.
The fines stem from Red Cross recalls carried out between 2003 and 2005 that could have been prevented, the FDA 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 must make to comply with FDA rules, including improved training and record-keeping.
The amended consent decree also gave the FDA the authority to immediately fine the Red Cross for violations.