The Food and Drug Administration recently fined the American Red Cross $5.7 Million for blood-safety violations. This fine is only the latest of several fines related to over 17 years of safety violations by the Red Cross.
In 2003, FDA inspectors evaluated blood handling by the Red Cross. To say the Red Cross’s negligence was obvious is an understatement.
The inspectors found shortcomings in quality assurance, inventory management, control of non-conforming blood products, donor screening and blood component manufacturing issues as well as other problems, according to the FDA.
After its inspection in 2003, the FDA fined the Red Cross $10 Million for problems related to its handling of blood products. In response, the Red Cross agreed to a plan to implement safety precautions to correct the unsafe practices. However, in 2005, FDA inspectors found that many of the planned means to detect, control and change the problems had not been implemented. The latest fine stems from the failure to make the required changes suggested in the 2003 settlement and plan.
This is overwhelming threat to the safety of everyone undergoing surgery or needing a transfusion. The Red Cross supplies over 40% of the blood to the nation’s medical providers.