Red Cross signs FDA decree for improved blood safety

APRIL 14–ROCKVILLE, Md.–The Food and Drug Administration says the American Red Cross has agreed to substantial revisions in its consent decree with the agency regarding the safety of the nation’s blood supply.

The revised consent decree includes financial penalties if, in the future, the Red Cross fails to comply with FDA laws and regulations.

In the original 1993 consent decree, the Red Cross agreed to establish clear lines of managerial control over a newly established comprehensive quality assurance system in all regions; to enhance training programs; and to improve computer systems, records management, and policies for investigating and reporting problems, including adverse reactions.

The revised consent decree includes many of the same substantive provisions, updated to provide a series of clear deadlines for completing specific requirements of the decree and addressing additional types of violations observed since the original consent decree was signed in 1993.

It also includes a comprehensive penalty scheme to address potential future violations. If ARC fails to comply with blood safety rules and revised decree requirements, FDA can assess penalties up to the following maximum amounts:


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