Nov 29 2006
Despite a promise three years ago to fix on-going problems, the American Red Cross is in trouble again for violating blood-safety laws.
The organisation faces a fine of $5.7 million, and has been accused of violating the terms of a 2003 consent decree.
That settlement resolved charges that the Red Cross had committed "persistent and serious violations" of federal blood safety rules dating back 17 years.
In 2004, the Red Cross implemented a plan, with the FDA's blessing, to detect, investigate, monitor and correct the sorts of problems repeatedly cited by government investigators.
The latest fine is being added to a tally of nearly $10 million in previous FDA penalties for violation of blood-safety laws, regulations.
This means the Red Cross now faces fines to the tune of more than $15 million.
It seems that in a letter dated the 21st of November, the Food and Drug Administration (FDA) said that the latest fine by the federal government covered quality assurance, inventory management, control of non-conforming blood products, donor screening and blood component manufacturing issues discovered during a 2005 inspection of a Red Cross facility on John Street in West Henrietta, NY.
The Red Cross has promised to devise a new plan to comply with FDA requirements and has also asked for an independent and comprehensive assessment of how it complies with FDA regulatory requirements.
According to the Red Cross it does not use donated money to pay fines, but instead relies on operating funds which include revenue from the sales of blood products.
The Red Cross provides more than 40 percent of the nation's blood supply by selling blood products to health facilities.
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