FDA Fines Red Cross
FDA has fined the American Red Cross $5.7 million for violating blood-safety laws and the terms of a 2003 consent decree aimed at correcting the organization's practices, AP/South Florida Sun-Sentinel reports (Bridges, AP/South Florida Sun-Sentinel, 11/28).
FDA during a 2005 inspection of a Red Cross facility in West Henrietta, N.Y., found shortcomings in quality assurance, inventory management, control of nonconforming blood products, donor screening and blood component manufacturing (Healy, USA Today, 11/28). The 29-day inspection uncovered 207 deviations from the organization's 2004 FDA-approved plan to detect, investigate, monitor and correct problems repeatedly cited by government investigators.
The plan was established after a 2003 consent decree settled charges that the Red Cross had committed "persistent and serious violations" of federal blood-safety rules over the previous 17 years (AP/South Florida Sun-Sentinel, 11/28). According to the Washington Post, the fine "appears to be the largest single penalty assessed" under terms of the 2003 settlement.
The organization has been fined a total of nearly $10 million for violations of the decree (Washington Post, 11/28). The latest fine was noted in an FDA letter dated Nov. 21 to Red Cross interim President and CEO Jack McGuire and posted Monday on FDA's Web site.
The Red Cross has until mid-December to submit a report detailing how it will comply with FDA requirements or receive additional penalties (AP/South Florida Sun-Sentinel, 11/28).
Red Cross spokesperson Sybil Miller said the organization will review the letter and develop a plan to address FDA's concerns within the next three weeks. "We have put things in place since the inspection and trained our staff. The good news is that people should not be worried about the blood supply, which is overall the safest it has been," Miller said, adding that that since the inspection, "[n]obody has reported any adverse effect associated with Red Cross blood" (Lamothe, Rochester Democrat and Chronicle, 11/28).
The Red Cross Board of Governors also has requested an independent and comprehensive assessment of how the organization complies with FDA regulations (AP/South Florida Sun-Sentinel, 11/28).