The American Red Cross, the biggest U.S. supplier of donated blood, was fined $9.59 million after regulators found 16 of the organization’s facilities failed to comply with blood-safety rules.
Food and Drug Administration inspectors found “significant violations” from April 2010 to October 2010, including inadequate “managerial control,” record-keeping and quality assurance, the agency said yesterday in a letter to the Washington-based organization.
The FDA didn’t find any evidence that the lapses led to any serious health consequences for blood recipients, said Mary Malarkey, head of compliance at the agency’s Center for Biologics Evaluation and Research.
“The safety of the nation’s blood supply is one of our top priorities, and we have no reason to believe that it has been compromised in any way,” Malarkey said yesterday in a phone interview. “It’s very important to note that people who need transfusions should continue to take their doctors’ advice, and we encourage people to donate blood.”
The FDA has been working “very closely” with Red Cross management “for quite some time now,” Malarkey said. “These are not current violations and we remain hopeful that their current management team will be able to deal with the situation.”
The fines issued are “primarily centered on an inspection conducted 15 months ago” at the organization’s Donor & Client Support Center in Philadelphia, the Red Cross said yesterday in an e-mailed statement.
“We are disappointed that the FDA believed it necessary to issue a fine for an inspection conducted so long ago and it is important to know we have already taken corrective steps to address those matters and that improvements in operations have been made,” the Red Cross said.
The organization said it is “fully committed to meeting all FDA standards, has made significant progress in working with the FDA to comply with their regulations and requirements, and continues to work on improving its performance.”
The fines were levied under a 2003 consent decree that set penalties for failing to follow U.S. standards aimed at preventing blood contamination. The FDA has cited the Red Cross 14 times since the legal agreement was reached, Malarkey said.
The agency fined the Red Cross $16 million in 2010 for mismanagement of blood products and manufacturing violations. Those lapses didn’t endanger any patients, the agency said at the time.