BEIJING, Sept. 9 (Xinhuanet) -- The U.S. Food and Drug Administration (FDA) announced Friday that the American Red Cross (ARC) is being fined 4.2 million U.S. dollars for violating blood safety laws.
The violations include failing to ask appropriate questions of potential donors and not following test procedures, said the FDA.
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.
In a statement at its official website, FDA said these fines were assessed under an amended 2003 consent decree that calls for significant financial penalties when ARC fails to comply with FDA regulations and consent decree provisions designed to ensure the safety of the nation's blood supply.
"We have no evidence that these violations resulted in serious health consequences," the FDA said.
Since entry of the 2003 consent decree and prior to this action, the FDA has issued the ARC seven similar letters and assessed a total of 5.7 million dollars in penalties.
In another 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 ARC is responsible for approximately 45 percent of the nation's blood supply. Other independent community-based blood centers together provide another 45 percent, and hospitals collect most of the remaining 10 percent.
The FDA continues to advise care providers and consumers that rigorous protections are in place and that the blood supply is safe. Improvements in donor screening procedures and the use of a variety of new tests in the last few years have made the U.S. blood supply safer from infectious diseases and other risks than it has been at any other time. Enditem
(Agencies)
