The American Red Cross has been fined more than $16 million by the FDA for violating federal regulations on collection and manufacturing of blood products.
The FDA announced that it was fining the American Red Cross for a number of violations of federal laws, as well as for violating a 2003 consent decree between the Red Cross and FDA that was reached after the company was previously fined for blood collection errors. However, the FDA said that despite the violations and the fines, inspectors never found any evidence that the Red Cross endangered patients or the nation’s blood supply.
The Red Cross’s fines total $16.18 million; including $9.79 million in fines for the mismanagement of blood products, and $6.39 million in fines for violating Good Manufacturing Practices. The violations came as a result of 12 FDA inspections conducted since February 2008 at Red Cross facilities across the country.
FDA inspectors found that on a number of occasions the Red Cross failed to promptly conduct adequate investigations, failed to develop and implement adequate corrective actions to resolve problems, and failed to ensure that problems did not reoccur.
Specifically, inspectors found instances of blood components or whole blood number mix-ups, and failure to properly track suspect blood or blood components. Suspect blood components are blood products which could carry the risk of a bloodborne disease or infection that could be transmitted to recipients of blood products, such as HIV or Hepatitis C. The suspect blood products were not distributed, according to inspection report letters sent by FDA to Red Cross.
The fines were assessed under a 2003 consent decree between FDA and Red Cross, reached between the agency and the non-profit organization after similar problems were discovered in 1993. The consent decree allows the FDA to impose significant fines on Red Cross when the organization fails to comply with federal blood collection regulations. Before the most recent fines, the Red Cross has been fined about $21 million by FDA since the consent decree.