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FDA Documents On The Red Cross

Below are quotes from hundreds of pages of Food and Drug Administration court documents on the American Red Cross:

"(T)he public health remains at unnecessary risk due to ARC's (American Red Cross's) recalcitrance ... RC continues to cosmetically treat symptoms rather than address the causes of its compliance problems. ARC continues to offer excuses rather than solutions ..."

It is "the longstanding practice of the ARC not to correct and prevent recurrence of KNOWN violations until after FDA becomes aware of them through inspections ... and insists that they be fixed ... Even when ARC gets around to addressing FDA's observations, it construes them as discrete deviations, without fixing the systemic problems ... Nor does ARC even investigate all the causes of problems, ensure the effectiveness of the limited corrective actions it takes belatedly, or prevent violations in the first place."

"ARC has repeatedly failed to ensure that it labels blood products correctly ... the resulting errors were widespread. ARC has had a recurring problem of failing to properly quarantine blood and control inventory."

"Since 1993, the FDA has sent eleven letters ... and other correspondence advising ARC of significant areas of noncompliance ... (P)roblems are not just theoretical; they have resulted in the distribution of unsuitable blood products. (B)lood products that tested positive for CMV (a virus that can cause blindness and death in some patients) ... were labeled as CMV-negative and distributed ... FDA learned the ARC was contacted by the Swiss Red Cross (that) had tested positive for hepatitis C. (T)he Southwest Region lost track of (blood that) tested positive for HIV. The HIV-positive component could not be located and it must be assumed was distributed and used."

"ARC's donor registration system is seriously flawed. For example, in October 1997, the Southern Region submitted 1,107 names of donors who tested positive for hepatitis C to ARC National Headquarters. However, this information was not reported to other regions until December 1998, 14 months later. The 14-month delay by National Headquarters resulted in products being released without the benefit of the protection afforded by an accurate national donor deferral registry."

ARC mishandles "information on donors who test positive for syphilis."
"During the February-April 2000 inspection of ARC National Headquarters, we observed ... ARC's Quality Assurance unit has repeatedly failed to identify critical deviations in the manufacture of blood products, and when deviations were identified ... Quality Assurance failed to thoroughly investigate the cause(s) of those errors, (and) failed to ensure that adequate corrective action was taken."

"ARC recalled ... or withdrew unsuitable components, and later shipped the same components, illustrating ARC's inadequte inventory and quarantine system."

"On April 28, 1999 ARC's South Carolina Region released an unsuitable blood component that had been recalled; the component was reshipped, in error, and transfused into a patient. On February 4, 2000 ARC's Southern California Region reshipped a component that had been previously withdrawn from the market (after an HIV and Hepatitis C test) ... the component ... was transfused on an unknown date. ARC's Ft. Wayne Region had reported that two Plasma products that were repeat reactive for HIV had been released for distribution, but not actually distributed."

Excerpt from Jay S. Epstein, M.D.; Director, Office of Blood Research and Review, at the Center for Biologics Evaluation and Research, FDA:

"Some of the observed conditions create an imminent and serious potential for harm to blood donors and recipients. Examples of areas of particular concern ... include system-wide errors in donor identifiction; collection of blood from donors with a documented history of risk factors that should be a basis for deferral; release of mislableled, test-positive blood ... and potentially hazardous blood sample collection methods. (T)he chronic and repetitive nature of ARC's violations -- many of the same violations occur over and over again, year after year -- make it impossible to assure that ARC poroducts generally meet their intended quality an safety characteristics."

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