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williamxiang

木虫 (著名写手)


[求助] 求这一段话的翻译-关于FDA有因检查的 已有1人参与

Directed and For Cause inspections may be initiated at both home districts' and headquarters' direction. These are priority inspections that are likely to be application/product specific. They can be referred from review divisions, forensic testing laboratories (based upon analysis of previously collected forensic samples) or result from CDER market surveillance or district surveillance, etc. Headquarter assignments will be coordinated and issued by HFD-324. A copy of the district-initiated "directed" or "for cause"  assignment should be forwarded to HFD-324 at the time of issuance.

法规英语不好的娃伤不起啊
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nbp_wyong

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【答案】应助回帖

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感谢参与,应助指数 +1
williamxiang: 金币+20 2014-01-28 10:35:35
大概意思是,如果审查过程中出现任何不合规的问题,就会进行有因检查,有因检查会在总部和地区都进行,审查将会优先对特定产品和申请进行,就审查部门,检验机构就之前的样品检验结果提出的情况、CDER 市场监管等提出的情况和问题进行审查。
2楼2014-01-24 13:40:15
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