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【medical-news】American Red Cross faces new fine over bloo
American Red Cross faces new fine over blood safety
By ANDREW BRIDGES
Associated Press
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WASHINGTON — The American Red Cross is facing another heavy fine over blood-safety violations, bringing penalties against the organization to more than $15 million despite a promise three years ago to fix the problems.
The Food and Drug Administration disclosed that it had fined the organization $5.7 million recently for continuing to violate blood-safety rules and failure to comply with a 2003 agreement aimed at correcting the unsafe practices.
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 the FDA Web site.
The Red Cross was given a mid-December deadline to produce a report on how it intended to comply with FDA requirements, or possibly be subject to additional penalties.
The latest fine is being added to a tally of nearly $10 million in previous FDA penalties for violation of blood-safety laws, regulations and the terms of the 2003 consent decree.
That settlement resolved charges that the Red Cross had committed "persistent and serious violations" of federal blood safety rules dating back 17 years.
In 2004, the Red Cross implemented a plan, with the FDA's blessing, to detect, investigate, monitor and correct the sorts of problems repeatedly cited by government investigators.
A 2005 inspection of a Red Cross facility in West Henrietta, N.Y. was supposed to be the first comprehensive evaluation of how the plan was working. But the federal inspectors, over 29 days, turned up 207 deviations from the plan, the FDA said.
The latest fine of $5.7 million stems from that inspection.
The inspectors found shortcomings in quality assurance, inventory management, control of non-conforming blood products, donor screening and blood component manufacturing issues as well as other problems, according to the FDA.
The Red Cross said it would devise a new plan to comply with FDA requirements. The Red Cross board of governors also has asked for an independent and comprehensive assessment of how it complies with FDA regulatory requirements.
The Red Cross does not use donated money to pay fines, but instead relies on operating funds, according to the organization. Those include revenue from the sales of blood products.
The Red Cross provides more than 40 percent of the nation's blood supply, selling blood products to health facilities. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 本文字符2078
American Red Cross faces new fine over blood safety
美国红十字会面临关于血液安全的新罚款
By ANDREW BRIDGES
Associated Press
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WASHINGTON — The American Red Cross is facing another heavy fine over blood-safety violations, bringing penalties against the organization to more than $15 million despite a promise three years ago to fix the problems.
美国红十字会由于违反血液安全面临另一个严重罚款，这次惩罚超过1，500，000美元。尽管在三年前就有休整这个问题的承诺。
The Food and Drug Administration disclosed that it had fined the organization $5.7 million recently for continuing to violate blood-safety rules and failure to comply with a 2003 agreement aimed at correcting the unsafe practices.
FDA公布在2003年就已对该组织违反血液安全规则罚款570，000美元，该组织并没有按照2003年协议改正不安全的步骤。
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 the FDA Web site.
最新的罚款通知FDA已于11月21日寄给红十字代理主席和CEO Jack McGuire，并于周一公布在FDA网站。
The Red Cross was given a mid-December deadline to produce a report on how it intended to comply with FDA requirements, or possibly be subject to additional penalties.
红十字会被要求在十二月中旬期限前提交如何按照FDA要求修改的报告，否则将要面临更严重的惩罚。
The latest fine is being added to a tally of nearly $10 million in previous FDA penalties for violation of blood-safety laws, regulations and the terms of the 2003 consent decree.
最近的罚款在上次FDA对2003年违反血液安全法，条例和条目的基础上增加了近1，000，000美元。
That settlement resolved charges that the Red Cross had committed "persistent and serious violations" of federal blood safety rules dating back 17 years.
这项断然的解决方法控告红十字会在17年来一直长期和严重违反联邦血液安全条列。
In 2004, the Red Cross implemented a plan, with the FDA's blessing, to detect, investigate, monitor and correct the sorts of problems repeatedly cited by government investigators.
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作者:admin@医学,生命科学 2011-04-30 05:11
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