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FDA Again Fines American Red Cross for Blood Safety Lapses; This Time $16 Million

Cheryl Clark, for HealthLeaders Media, June 18, 2010

The current $16 million fine is the latest in a string of safety issues and problems with the American Red Cross stemming back to 1993, when federal officials entered into a consent decree with the blood collection, testing and distribution organization. That decree called for significant improvements in safeguarding the blood supply.

In 2003, the consent decree was amended to allow the FDA to impose fines for failure to comply with agency regulations. The amended decree outlines requirements for the American Red Cross to implement a variety of safeguards to ensure the safety of the supply, the agency said.

Since 2003, the American Red Cross has made progress to address its quality issues, such as standardizing procedures, upgrading national testing laboratories and increasing oversight, the FDA said.

"However, to fully comply with federal regulations and consent decree provisions, the American Red Cross must make swift, additional progress on all of the issues the FDA has identified," the agency said.

The FDA said it has sent 12 similar letters to the American Red Cross and imposed more than $21 million in fines under terms of the amended decree.

"However, to fully comply with federal regulations and consent decree provisions, the American Red Cross must make swift, additional progress on all of the issues the FDA has identified," the agency said.


Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists.
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