The Food and Drug Administration on Thursday fined the American Red Cross $16 million, alleging that the organization had been slipshod in the collection and manufacture of blood products. It was the latest in a string of multimillion-dollar penalties for failure to meet blood safety standards.
Despite the most recent violations, there is no indication that patients or the blood supply were endangered, “and the blood supply is believed to be safe,” the FDA said in a statement.
The penalties resulted from FDA inspections of a dozen Red Cross facilities across the nation in 2008 and 2009 that identified multiple failures to investigate and correct sloppy processing of blood products and a failure to maintain quality controls.
The FDA said that it was encouraged by recent actions by the Red Cross’ leadership to improve blood safety and that it was “hopeful these fines will encourage the Red Cross to act more quickly” to comply with safety regulations.
The fines bring to $37 million the total penalties for substandard blood handling procedures levied against the Red Cross since 2003. In that year, a consent decree in place since 1993 was amended to let the FDA impose fines.
In a statement, the Red Cross said many of the incidents cited by the FDA took place before corrective action was taken.
The Washington-based charity said it was “fully committed to meeting all FDA standards” but was “disappointed that the FDA believed that it was necessary to fine us for prior violations dating back several years.”
The Red Cross collects and processes about 43% of the nation’s blood supply and produces blood products including red cells, plasma and platelets.
A Red Cross spokeswoman said fines were paid out of the agency’s operating budget, which comes from fees paid by hospitals for blood services, and not from donations.