US Red Cross fined 16mn dollars over blood safety

The US FDA said Thursday it is fining the American Red Cross 16mn dollars.

Washington: The US Food and Drug Administration said Thursday it is fining the American Red Cross 16 million dollars for not complying with regulations on the collection and manufacture of blood products.
Despite the violations, the FDA said 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 has made progress since 2003 in correcting quality problems.

It cited the standardization of procedures, the modernization of national laboratories that test blood and the strengthening of the organization`s internal controls.

But 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 dollars since an amended 2003 consent decree.

Bureau Report

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