WASHINGTON – The federal government has fined the American Red Cross a record $5.7 million for violating blood-safety laws and the terms of a 2003 consent decree.
The fine covers quality assurance, inventory management, control of non-conforming blood products, donor screening and blood component manufacturing issues turned up during a 2005 inspection of a Red Cross facility in West Henrietta, N.Y., the Food and Drug Administration said in a Nov. 21 letter.
The fine appears to be the largest single penalty ever assessed under terms of a 2003 court settlement that allows the large fines when the Red Cross violates FDA rules. Previously, the FDA had fined the Red Cross a total of nearly $10 million.
"We will review the letter, which we are doing now, and if we have any questions or issues that we want to resolve, we will get back with the FDA," American Red Cross spokesman Ryland Dodge said.
Messages left with two FDA representatives were not immediately returned.