The Food and Drug Administration has fined the American Red Cross $16 million for violating blood safety laws and other regulations. Fortunately, it appears no patients were harmed and the blood supply is still safe. The Red Cross was fined for violating federal law during collection and processing of blood in 2008 and 2009. Among the problems were mislabeling of blood, failing to record complete information about donors and potential air contamination. The FDA, which periodically inspects Red Cross operations, notified the charitable organization last October of the failure to investigate and identify problems and take preventive action during its blood processing operations.
With four million blood donors, the Washington, D.C.-based organization is the largest supplier of blood, plasma and other blood products in the United States. The $16 million fine is only the latest penalty assessed against the organization. The FDA has already sent 12 letters to the American Red Cross and imposed over $21 million in fines since 2003, not including this most recent fine. According to the FDA, the Red Cross has taken significant steps to correct the problems.
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