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American Red Cross Fined $4.2 Million by the FDA
 

On September 8, 2006 the U.S. Food and Drug Administration (FDA) announced that the American Red Cross (ARC) was being fined $4.2 million for its failure to comply with requirements under FDA regulations and federal laws related to the collection of blood products.

The fine was levied in accordance with an amended 2003 consent decree that called for “significant financial penalties” if ARC fails to cooperate with FDA regulations.

In a recently completed review of all ARC blood product recalls from 2003 to 2005, the FDA found that the recalls were preventable. The violations made by the ARC involve disregarding the “Good Manufacturing Practice,” standards, a failure to ask appropriate donor screening questions and a failure to adhere to manufacturer test protocols.
 
The FDA strongly reminded the blood industry of its need to adhere strictly to regulations meant to ensure blood safety. The agency stated that it had no evidence that these specific violations resulted in serious health consequences. 

Read the entire FDA statement at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01447.html

Source: FDA Statement released on September 8, 2006

 

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