GTCB ZGEN etc. FDA Fines Red Cross $4.2 Million Over Blood-Collection Violations
[The U.S. blood supply may be less safe than people think. Without question, I would rather get a plasma protein such as thrombin or antithrombin from a recombinant source than from plasma.]
WASHINGTON -- The Food and Drug Administration said Friday it is fining the American Red Cross $4.2 million for violating federal blood-collection rules.
The FDA said in a statement that it is not aware of any serious health consequences as a result of the violations, which include failures by the Red Cross to ask appropriate donor screening questions and failure to follow manufacturer test protocols used to screen blood for infectious diseases.
The fines stem from a recently completed FDA review of recalls conducted by the Red Cross between 2003 and 2005. The FDA said the events leading to the recalls "were entirely preventable" by the American Red Cross.
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.
It isn't immediately clear whether any of the recalled blood has entered the blood supply. <<
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