FDA fines Red Cross more than $9.5 million

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A hefty fine for significant violations from the FDA totaling more than $9.5 million hit the Red Cross on Jan. 13.

In 2010 the FDA  inspected 16 different American National Red Cross facilities, according to a letter addressed to J. Chris Hrouda, executive vice president of Biomedical Service at the Red Cross. The letter outlines  numerous violations of the Red Cross and lists financial penalties.

According to a 2009 AABB survey, donors give about 17 million units of blood every year and the Red Cross transfuses about 15 million units. BYU students are included among those donors as the campus is often filled with blood drives serviced by the Red Cross.

Paige Bryson, a senior from Bountiful, studying conservation biology, has donated blood four times at BYU for both the Red Cross and Mountainstar blood services.

“The people from Mountainstar were more professional than the Red Cross,” Bryson said. “They were confident in what they were doing and never had to stab me twice because they always got my vein the first time.”

Violations in the letter included inadequacies in all of the following: training, record keeping, distribution of blood and quality assurance.

“The safety of the blood supply depends on effective screening of donors to identify risk factors for diseases transmissible by blood … and the deferral of high-risk potential donors,” the letter states.

The Red Cross did not establish an accurate or complete list of permanently deferred donors, according to the letter.

Red Cross spokespeople claim the violations center on an inspection completed 15 months ago and the agency has solved many of the issues.

“We are disappointed that the FDA believed it necessary to imposed a fine for an inspection conducted so long ago,” wrote Stephanie Millian, director of biomedical communications, in an MSNBC article. “We are not aware of any adverse donor reactions or patient issues due to the problems in the FDA report.”

After hearing about the FDA fine, Bryson said the news reaffirmed her preference for Mountainstar.

“[The Red Cross] is not going to do anything that would kill me,” Bryson said. “I just like Mountainstar better and felt safer giving blood to them.”

Evelyn Bonnin, director of FDA’s Baltimore District, wrote in an MSNBC article that the Red Cross has known about the problems and failed to correct the issues.

Even with the fine and violations on the Red Cross, the FDA has not found any harm done to blood donors. The FDA recommends individuals with a strong health history continue to be or become blood donors.

To view the full letter to the Red Cross, visit fda.gov.

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