“We have 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 going forward.”
BY MOLLY PETERSON
BLOOMBERG NEWS
WASHINGTON — The American Red Cross, the biggest U.S. supplier of donated blood, has been fined $9.59 million after the Food and Drug Administration found that 16 of its facilities failed to comply with blood-safety rules.
FDA inspectors found “significant violations” from April 2010 to October 2010, including inadequate “managerial control,” record-keeping and quality assurance, the agency said Friday in a letter to the Washington-based organization.
The FDA didn’t find any evidence 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 in a telephone 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 Red Cross didn’t immediately respond to an email sent to its spokesmen after business hours.
“We have 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 going forward.”