FDA fines Red Cross $16 million for safety lapses

WASHINGTON Thu Jun 17, 2010 10:37pm EDT

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WASHINGTON (Reuters) - The \Food and Drug Administration has fined the American Red Cross $16 million for violating blood safety laws and other regulations, but said no patients were harmed and the blood supply is still safe.

The FDA said on Thursday 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 the fine announced on Thursday.

The FDA said the Red Cross had taken significant steps to correct the problems.

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Comments (2)
Is that the FDA hiding behind the billboard, waiting to fine anyone they catch for minor violations? These cases undermine the public trust in both the American Red Cross and the FDA.

Jun 18, 2010 7:36pm EDT  --  Report as abuse
so, instead of my donation going to help people, it is going to the gpvernment???

Jun 18, 2010 9:47pm EDT  --  Report as abuse
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