FDA Fines Red Cross $4.2 Million for GMP Violations
Agency says Red Cross failures led to potentially preventable product recalls
FRIDAY, Sept. 8 (HealthDay News) -- The U.S. Food and Drug Administration has fined the American Red Cross $4.2 million for failure to comply with Good Manufacturing Practice (GMP) during blood product collection, which led to potentially preventable recalls between 2003 and 2005. Although the violations did not result in any serious health problems, the American Red Cross failed to ask donors appropriate screening questions and did not always follow manufacturers' test protocols, according to the FDA.
A 2003 consent decree allows the FDA to assess fines if the Red Cross does not follow federal laws and FDA regulations. In the past, the Red Cross has been sent seven similar letters and fined $5.7 million. The American Red Cross supplies about 45 percent of donor blood in the United States.
"While achieving a blood supply with zero risk of transmitting infectious disease is the ultimate objective, we recognize based on the available science that this may not be realistic," according to an FDA statement. "Therefore, the FDA requires blood processors to adopt and strictly follow a multi-layered safety program to protect and enhance the safety of blood products at each stage of their manufacture."