【讨论】周五印度又一制药公司被拿下

zhulikou431

The manufacturer : IND-SWIFT LIMITED
Site address :        OFF NH-21 VILLAGE JAWAHARPUR, TEHSIL DERA BASSI, DISTRICT SAS NAGAR (MOHALI), PUNJAB, PIN-140507, India
Nature of non-compliance : It was not possible to confirm the validity of stability testing data. Several falsified and inaccurate results had been reported in long term stability and batch testing. Discrepancies between electronic data and those results formally reported were identified. Established processes to verify data accuracy and integrity had failed and there had been no formal investigation raised by the company. The company provided commitments to address the data integrity concerns and initiated a wider review of quality critical data. Additional discrepancies were identified in process validation and release data. During on-going communications with the licensing authority regarding the data review, the company failed to disclose data integrity issues for all products. No satisfactory explanation was given for this discrepancy.

fireflame

很好奇，FDA是如何查到这样的数据的呢？

豫北风云

fireflame 发表于 2014-3-24 16:07
很好奇，FDA是如何查到这样的数据的呢？

来自丁香园转帖，好奇啥？

fireflame

豫北风云 发表于 2014-3-24 16:10
来自丁香园转帖，好奇啥？

额，好奇发现的过程，和从哪儿来的转贴没关系吧。。。

lunmulunmu

外文差，看不明白呀

北方的狼

FDA究竟要干什么

彩虹

又一制药公司中枪的

豫北风云

fireflame 发表于 2014-3-24 16:14
额，好奇发现的过程，和从哪儿来的转贴没关系吧。。。

你如果不知道原来帖子，你再这里问十天，也没有人解答，因为这个1信息不是FDA的信息，是其他机构信息。

fireflame

ok,thanks~