FDA Finds Violations at Red Cross Exposing Blood to Safety Risks

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FDA Finds Violations at Red Cross Exposing Blood to Safety Risks

Wall Street Journal (www.wsj.com) (12/04/00) P. B15

The Food and Drug Administration (FDA) said last week that even with close government inspection, there are still problems at the American Red Cross that could possibly endanger the nation's blood supply. An FDA inspection of Red Cross headquarters earlier this year revealed violations of manufacturing standards, including a quarantine system that did not keep unusable blood from being released and a failure to follow directions for HIV tests. The blood agency has been under a consent decree with the FDA for the past seven years, during which time the FDA has sent the Red Cross 10 letters regarding problems found during reviews. The FDA's latest findings appeared in briefs filed in U.S. District Court in Washington last week as part of the agency's efforts to amend the decree so it could fine the Red Cross for further violations. Red Cross head Bernadine Healy said the blood agency has started borrowing $100 million to make improvements in the system.
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