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FDA Fines Red Cross $16 Million

June 18, 2010

On Thursday, the U.S. Food and Drug Administration said it is fining the American Red Cross $16 million for not complying with regulations on the collection and manufacture of blood products.

The FDA said that despite the violations, it found no evidence that patients were in any danger and that the blood collected by the Red Cross was believed to be safe.

“Multiple layers of safeguards are in place to protect and enhance the safety of blood products,” the FDA said in a statement.

“However, these types of violations decrease the assurance that blood products manufactured by American Red Cross will continue to be safe and have the potential to compromise the safety of the blood supply,” it said.

The FDA also said it was “encouraged by recent efforts made by the Red Cross leadership and will work closely with them to achieve full compliance.”

The agency said the American Red Cross made progress since 2003 in correcting quality problems.

The FDA said the standardization of procedures, the modernization of national laboratories that test blood and the strengthening of the organization’s internal controls.

However, it said the American Red Cross “must make swift, additional progress on all of the issues the FDA has identified.”

The FDA has sent the American Red Cross dozens of similar letters and imposed fines totaling $23 million since an amended 2003 consent decree.

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