U.S. Food and Drug Administration
FDA Fines American Red Cross $16 Million for Prior Failures to Meet Blood Safety Laws
Published in Medical Letter on the CDC and FDA, July 4th, 2010
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.
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