Red Cross Fined Nearly $9.6 Million Over Blood Safety Lapses
The American Red Cross is facing a hefty fine from U.S. health officials regarding lapses in blood safety management.
The recent Food and Drug Administration sanctions are the second the agency has faced over the last two years due to failure to correct violations regarding blood safety rules. The organization was fined in June 2010 over manufacturing violations and mismanagement of blood products.
The current fine is with regards to practices that violated blood safety rules and resulted in mishandled and misplaced blood. The violations pose a threat to both donors and the nation’s blood supply.
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However, the FDA did not find that the violations led to any serious health consequences and urged donors and urged patients to continue to follow medical advice with regards to blood transfusions.
The fine follows FDA inspections at 16 Red Cross locations throughout the United States conducted in 2010. The Red Cross misconduct is described in a 32-page letter sent to the organization by the FDA on Jan. 13.
“Many of the violations recounted in this letter are virtually identical to violations charged (previously),” the public letter read.
The American Red Cross, the largest supplier of donated blood in the United States, has issued a response to the FDA letter, maintaining that the organization is “fully committed to meeting all FDA standards.”
“We are disappointed that the FDA believed it necessary to issue a fine for an inspection conducted so long ago and it is important to know we have already taken corrective steps to address those matters,” the organization said in its statement.
“The blood supply is safer today than ever before, and people should not hesitate to give or receive blood. Giving blood helps save lives, and we appreciate all those who help others in need by giving blood,” the organization added.
