FDA Fines Red Cross $4.2 Million Dollars for Violating Safety Rules

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The U.S. Food & Drug Administration (FDA) has fined the American Red Cross $4.2 million dollars for failure to comply with federal law and FDA regulations regarding the collection of blood products. These fines were assessed based on an amended 2003 consent decree that called for substantial financial penalties when the Red Cross fails to comply with FDA regulations and provisions of the consent decree designed to ensure the safety of the nation's blood supply.

These fines resulted from a recent FDA review of Red Cross recalls between 2003 and 2005 which concluded that the events should have been prevented by the Red Cross. The violations included breaches of good manufacturing practices such as the failure to ask appropriate donor screening questions and failure to follow test protocols.

Improvements in the procedures for donor screening as well as a variety of new tests in the last few years, have made the nation's blood supply safer from infectious diseases and other risks that at any time in the past. There is, however, always some degree of risk in receiving blood products and each safeguard is considered critical to minimizing that risk. Failure to perform a particular safeguard does not automatically mean the release of unsafe blood products, but it does increase the potential for risk. The FDA has insisted that the Red Cross Board of Directors prioritize and support its new managements ability to immediately address and work to improve its quality practices.

The $4.2 million dollars in new fines are in addition to $5.7 million dollars in prior assessments.