The FDA has fined the American Red Cross $4.2 million for violating federal rules designed to ensure the safety of the blood supply. The violations included failing to ask appropriate donor screening questions and failing to follow testing protocols.
The recall involved roughly 12,000 units ofblood, some of which had entered the blood supply, according to the Wall StreetJournal. There was no evidence of serious health consequences from the violations. The problems were discovered during a review of blood recalls between 2003 and 2005.
Before Friday's action, the FDA had fined the Red Cross a total of $5.7 millionin previous years. Friday's action also requires the Red Cross to establish better managerial control of its quality assurance program, improve training, and enhance its system for investigating and reporting problems.
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