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American Red Cross Fined $4.2m for Improper Blood Screening

The FDA fined American Red Cross a record $4.2 million for improper screening of potential blood donors and also for other safety problems//.

The Food and Drug Administration yesterday disclosed the fine amount which follows $5.7 million in previous fines since 2003, calling attention to a disturbing pattern of quality control failures.

The Red Cross is a humanitarian organization which depends heavily on volunteers, handles about 45 percent of the nation's blood supply. The Red Cross follows FDA rules for the identification as well as barring of donors with infectious diseases like AIDS, West Nile viral disease, the human form of mad cow disease, etcetera.

The agency stated that the nation's blood supply remained safe and advised patients in need of a blood transfusion to follow the advice of their physicians.

The Red Cross was made to remove around 12,000 units of questionable blood and blood products from its shelves. Following this they voluntarily recalled it from hospitals and treatment centers across the nation. According to the FDA, the recalls ``were preventable."

None of the recalled units had any evidence of contamination with a transmissible infectious agent. However the agency did acknowledge that in such voluntary blood recalls patients who received blood from batches that were later recalled were not routinely tracked.

A 2003 consent decree governs the Red Cross which permits the FDA to levy significant fines for failure of compliance with federal regulations. The organization said it takes the fine ``seriously" and ``is committed to full compliance."

Margaret Glavin, FDA's associate commissioner for regulatory affairs said, ``It is not acceptable that the quality system has failed in this way." The agency did order the Red Cross to review the quality-control breaches that have occurred and to take actions to ensure that it is not repeated.

The Red Cross has said
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