美国FDA：太阳医药可能面临的另一个进口警报

清歌一曲月如霜

美国FDA：孙医药可能面临的另一个进口警报
据印度金融门户业务标准和货币资金内部控制，美国FDA已经开始在Sun制药的Halol工厂一个惊喜审核周一11，2014年。
这可以被看作是在该设施，并通过美国FDA于阳光Karkhadi厂送达的进口警报生产多种产品召回的后果。在警告信FDA的离开毫无疑问，主要的原因发出进口警报该工厂是数据造假。以下兰伯西和Wockhardt公司，显然孙制药正在处理已知的相同的道德问题是真的很难克服。 FDA已，除其他事项外，建议委任AATA完整性顾问，以确定哪些个别经理人有能力影响有关cGMP要求的数据完整性。
特别是当与兰巴克斯和Wockhardt公司相比，可以预计，该数据的欺诈，不仅将在SUN Karkhadi植物中找到，但在Halol植物，以及。
来源：
美国FDA：警告信


FDA: SUN Pharma may face another Import Alert
According to the Indian financial portal Business Standard and Money Control, the US FDA has started a surprise audit at the Halol Plant of SUN Pharma on Monday 11, 2014.
This can be seen as a consequence of the recall of multiple products produced in this facility and also to an import alert served by the FDA to the SUN Karkhadi plant. In its Warning Letter the FDA left no doubt, that the major reason for issuing an import alert for that plant was data fraud. Following Ranbaxy and Wockhardt, obviously SUN Pharma is dealing with the same ethical problems which are known to be really difficult to overcome. The FDA has, among other things, recommended to appoint a aata integrity consultant and to determine which individual managers are in a position to influence data integrity regarding cGMP requirements.
Especially when compared with Ranbaxy and Wockhardt, it can be expected, that data fraud will not only be found at the SUN Karkhadi plant, but at the Halol Plant, as well.
Source:
FDA: Warning Letter

道路漫长黑暗

谢谢楼主翻译，虽然还实希望楼主能校对一下

yuansoul

道路漫长黑暗 发表于 2014-9-21 12:37
谢谢楼主翻译，虽然还实希望楼主能校对一下

反对，又不是他翻译的。

yuansoul

“ @秋天的风  孙医药?这是蒲公英英语啊？  发表于 半小时前” 因为是大写，所以没有识别出太阳之子

一沙一叶

看看英语吧  

瀚海风云713

数据造假不只是发生在中国呀

syhorchid

孙医药？洋泾浜！

windli

阿三医药行业问题大   以前老板合作过   造假币天朝还厉害     所以DMF拿了那么多

xqliu

阿三应该是高手，国内也不差，但是总一天要还的。