US regulator fines American Red Cross $16 million for blood safety lapses

The US Food and Drug Administration (FDA) announced today that it had fined the American Red Cross $16 million for prior failures to comply with federal laws and regulations related to the collection and manufacture of blood products.

Despite the compliance failures, FDA said that it found no evidence that the Red Cross violations endangered any patients and the blood supply is believed to be safe.

Although there are multiple layers of safeguards in place to protect and enhance the safety of blood products, the FDA said that 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.

The FDA assessed fines totalling $16.18 million, $9.79 million for violations related to mismanagement of certain blood products and $6.39 million for Good Manufacturing Practice violations. Blood products include red cells, plasma and platelets.

The FDA said it hoped that these fines would encourage the Red Cross to act quickly to take necessary action to address and correct the issues that have contributed to these violations and that it would work closely with the Red Cross to achieve full compliance.

In October 2009, the agency notified the American Red Cross that FDA inspections conducted during 2008 and 2009 revealed violations that included failure to identify problems that occur during manufacturing and failure to adequately investigate the identified problems.