The FDA has announced that the American Red Cross has been fined $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 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.
The FDA assessed fines totaling $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.
FDA is encouraged by recent efforts made by the Red Cross leadership and will work closely with them to achieve full compliance. 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.
In October 2009, the agency notified the American Red Cross that FDA inspections conducted during fiscal years 2008 and 2009 revealed violations that included failure to identify problems that occur during manufacturing and failure to adequately investigate identified problems.
The fines announced today were assessed under an amended 2003 consent decree that outlines requirements for the American Red Cross to ensure safety of the nation’s blood supply.
The original 1993 decree was amended in 2003 to allow the FDA to impose significant fines for failure to comply with agency regulations and provisions designed to ensure the safety of the nation’s blood supply.
Since 2003, the American Red Cross has made progress addressing some of its quality issues, including standardizing procedures, upgrading its National Testing Laboratories, and increasing oversight of the organization. However, to fully comply with federal regulations and consent decree provisions, the American Red Cross must make swift, additional progress on all of the issues the FDA has identified.
The agency has previously sent 12 similar letters to the American Red Cross and imposed a total of more than $21 million in fines under terms of the amended 2003 consent decree.
The American Red Cross is one of several organizations that is responsible for the nation’s blood supply.