On June 17, 2010, the Food and Drug Administration (FDA) fined the American Red Cross (ARC) $16.18 million for failure to address problems with the processing of blood products. ARC is the largest U.S. supplier of blood, plasma and other blood products with an average of four million donors.
The fine was issued after FDA inspections of a dozen ARC facilities conducted across the U.S. in 2008 and 2009. FDA inspectors found multiple examples of ARC’s failure to correct shoddy practices related to the collection and manufacture of blood products. Some of the infractions included mislabeled blood, failure to record complete donor information and potential air contamination.
ARC’s noncompliance with federal laws and regulations compelled the FDA to take action. The fines were assessed under an amended 2003 consent decree--the original decree was in 1993--that outlines requirements for ARC to ensure safety of the nation’s blood supply. According to the FDA, since 2003, ARC has made progress addressing some of its quality issues, including standardizing procedures, upgrading its National Testing Laboratories and increasing oversight. However, to be in full compliance ARC needs to make “swift, additional progress” on all of the issues outlined by the FDA.
“The FDA is hopeful these fines will encourage the Red Cross to act more quickly to take the actions necessary to address and correct the issues that have contributed to these violations,” explained the agency.
“Despite the compliance failures, FDA found no evidence that the Red Cross violations endangered any patients and the blood supply is believed to be safe. Multiple layers of safeguards are in place to protect and enhance the safety of blood products. However, these types of violations decrease the assurance that blood products manufactured by American Red Cross will continue to be safe and have the potential to compromise the safety of the blood supply,” said the FDA in its statement.
Since 2003, the FDA has fined ARC $21 million, excluding the June 17, 2010 fine.
Source: The Los Angeles Times (online), June 18, 2010, Reuters (online), June 18, 2010