This article was originally published in The Gray Sheet
FDA and the American Red Cross fail to identify a mutually acceptable system of prospective fines for future blood bank safety violations after sixteen months of negotiations related to quality assurance oversight of blood donations. According to FDA, the Red Cross has not abided by a 1993 consent decree in which it promised to make significant improvements in blood safety oversight at its national headquarters and regional facilities. On Dec. 11, the agency asked a federal court for authority to impose prospective fines against the Red Cross for future violations in order to force conformance to the consent decree...
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