Health Safety News: FDA fines Red Cross $16M for blood safety violations

Health Safety News: FDA fines Red Cross $16M for blood safety violations


06/21/2010 // West Palm Beach, FL, USA // Sandra Quinlan // Sandra Quinlan

Washington, DC—The American Red Cross was fined with regard to violations of blood safety laws and other policies on Thursday, June 17, 2010. The U.S. Food and Drug Administration (FDA) proposed the $16 million fine, which is the most recent penalty assessed against the charitable organization, according to information provided by Reuters.

Upon performing a routine inspection of the Red Cross and its operations, the FDA discovered several infringements on behalf of the organization. Such violations reportedly included “mislabeling of blood, failing to record complete information about donors and potential air contamination” during 2008 and 2009.

The FDA notified the Red Cross of its alleged failure to probe and recognize issues within the organization in October. The Red Cross also reportedly failed to take precautionary steps as a means of preventing safety hazards from arising during processing procedures.

Since 2003, the FDA imposed over $21 million in fines, excluding the latest $16 million fee, against the American Red Cross. The administration also sent the Red Cross 12 letters.

The American Red Cross has since then taken the initiative to correct the known problems. Reports indicated no patients suffered any adverse conditions or injuries in connection with the violations and fines. Additionally, the blood supply remains safe and secure.

Legal News Reporter: Sandra Quinlan- Legal News for Product Liability Lawyers.

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