government
American Red Cross fined for unsafe blood practices
NEWS IN BRIEF — Posted Jan. 30, 2012
After a seven-month investigation, the Food and Drug Administration has fined the American Red Cross more than $9 million for unsafe blood donation practices.
The agency inspected 16 Red Cross blood services facilities between April and October 2010 and found significant violations, according to an FDA letter sent Jan. 13 to the Red Cross. Violations included inadequate managerial control, inadequate donor register recordkeeping and failure to comply with reporting requirements (link).
The Red Cross is required to fix the errors within 60 days of the FDA's letter. In a statement, the Red Cross said it was disappointed the FDA "believed it necessary to issue a fine for an inspection conducted so long ago." The organization already has taken corrective steps to address the issues reported, the organization said, noting it was not aware of any adverse donor reactions or other patient issues due to the problems listed in the FDA report.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2012/01/30/gvbf0130.htm.
