The Food and Drug Administration fined the American Red Cross $9.6 million because of multiple violations found at the not-for-profit's blood-services facilities, less than two years after the agency fined the organization $16 million for other violations.
FDA fines Red Cross $9.6 million
The FDA said in a Jan. 13 letter that the Red Cross violated laws and regulations, as well as an amended consent decree of permanent injunction that the agency established with the Red Cross in 2003.
Among the violations listed in the letter, the FDA cited inadequate managerial controls over quality assurances, mismanagement of records, failure to establish a distribution-and-receipt procedure that could identify a unit of blood in the case of a recall, and inadequate staffing and training.
The agency said it conducted inspections at 16 Red Cross facilities in 2010. The previous fine, announced in June 2010, stemmed from violations that occurred during FDA inspections in fiscal 2008 and 2009.
“Many of the violations recounted in this letter are virtually identical to violations charged in previous” adverse determination letters, the FDA said in the 32-page letter. The Red Cross “has known of these continuing problems and has failed to take adequate steps to correct them.”
The Red Cross said in a written statement that the fine focuses on one inspection conducted at a donor and client support center in Philadelphia more than a year ago. The not-for-profit also said it is addressing other issues cited by the FDA in the letter.
“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. “We are not aware of any adverse donor reactions or patient issues due to the problems in the FDA report.”
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