2010年6月24日木曜日

FDA 米赤十字に罰金1600万ドル

FDAは米赤十字に罰金15億円を科した。
 FDAは、輸血用の血液などの米国内最大手の米赤十字社に1600万ドルの罰金
を科したと発表した。

米赤十字社の違反
提供者の血液ラベルの誤明記

以前から、血液採取の際の消毒不足、血液検査が不十分等の問題が指摘され
ていたが、米赤十字の記録不備により、FDAによる監査が不適合となり、
書簡による改善と罰金による制裁を受けたようだ。

米赤十字は、400万人の献血者を抱え、血液、血漿、その他の血液製剤の
もっとも大きな供給元。

米赤十字広報担当
二年前から、システムを変更し、法令順守するように改善した。
罰金は、改善前のもの。

2008年の米国内での回収率は0.08%とのことだが、加工製剤が輸入される
こともあり、気分はよくない。


---米当局、赤十字に罰金15億円 血液採取などで違反---
2010 年6月19日13時50分
http://www.asahi.com/international/update/0619/TKY201006190153.html

 【ブラス(米ルイジアナ州)=勝田敏彦】米食品医薬品局(FDA)は17日、輸血用の血液などの米国内最大手の米赤十字社に1600万ドル(約15億円)の罰金を科した、と発表した。血液の採取や、製品加工に連邦法違反などがあったとしている。
 米赤十字社は、血液から採った赤血球や血小板などを病院向けに販売している。FDAによると、今回見つかった違反で加工品の品質が損なわれる可能性があり、昨年10月、米赤十字社に書簡を送って改善を求めていた。ただ、問題発生を防ぐ措置も取られているため、安全性には問題はないと考えられるとしている。
 FDAは2003年以降、米赤十字社へ同様の書簡を12回送っており、今回の分を除いて2100万ドル(約19億円)以上の罰金を科している。


---FDA fines Red Cross $16 million for safety lapses---
Jon Lentz
WASHINGTON
Fri Jun 18, 2010 11:32am EDT
http://www.reuters.com/article/idUSTRE65H3JX20100618

(Reuters) - The Food and Drug Administration has fined the American Red Cross $16 million for violating blood safety laws and other regulations, but said no patients were harmed and the blood supply is still safe.

he FDA said on Thursday the Red Cross was fined for violating federal law during collection and processing of blood in 2008 and 2009.

Among the problems were mislabeling of blood, failing to record complete information about donors and potential air contamination.

The FDA, which periodically inspects Red Cross operations, notified the charitable organization last October of the failure to investigate and identify problems and take preventive action during its blood processing operations.

With four million blood donors, the Washington, D.C.-based organization is the largest supplier of blood, plasma and other blood products in the United States.

The $16 million fine is only the latest penalty assessed against the organization. The FDA has already sent 12 letters to the American Red Cross and imposed over $21 million in fines since 2003, not including the fine announced on Thursday.

The FDA said the Red Cross had taken significant steps to correct the problems.


---UPDATE:FDA Fines Red Cross $16M For Blood-Safety-Law Failures---
JUNE 17, 2010, 6:09 P.M. ET
http://online.wsj.com/article/BT-CO-20100617-714620.html?mod=WSJ_latestheadlines

The Food and Drug Administration announced Thursday that it fined the American Red Cross $16 million for alleged failures to comply with laws and regulations related to the collection and manufacture of blood products.

The government agency noted that despite the compliance failures, it found no evidence that the Red Cross violations endangered any patients and the blood supply is believed to be safe. However, it said the types of violations decrease the assurance that blood products manufactured by the Red Cross will continue to be safe and the failures have the potential to compromise safety standards.

Red Cross spokeswoman Stephanie Millian said the organization was "disappointed that the FDA believed it necessary to fine us for prior violations dating back several years." She added the Red Cross has made "significant progress over the past two years" in improving its regulatory compliance by implementation of system-wide changes.

A majority of the fine against the Red Cross, which is the largest supplier of blood and blood products in the U.S., was related to the mismanagement of certain blood products, according to the FDA, with the rest of the fine stemming from manufacturing-practice violations.

The FDA did note it was encouraged by recent efforts by the Red Cross to achieve full compliance. Since 2003, the Red Cross has made progress addressing some quality issues, according to the FDA, including standardizing procedures and upgrading its national testing laboratories. The FDA has imposed more than $21 million in fines under terms of an amended 2003 decree that allows the FDA to impose significant fines for failure to comply with agency regulations.

Millian said many of the incidents cited by the FDA occurred prior to the improvements made by the Red Cross. She said that 98% of the events identified by the FDA took place before 2008 and the recalls cited represented about 0.08% of the group's blood products.

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