北京太洋被FDA发布进口禁令

julia朱玉姣

公司名称：Beijing Taiyang Pharmaceutical Industry 北京太洋药业
地址：No 1 Shuangqiao (E) Road                 , Chaoyang,                Beijing CHINA 中国北京市朝阳区双桥东路乙1号
发布时间：2016-4-29

毒手药王邓智先

图片挂了

zysx01234

是祸躲不掉

北重楼

是因为483警告信吗

kslam

FDA已经没有时间写警告信。所以估计数据伪造情况很糟。有进口禁令可先消除灾难。

wizardwisdom

有图有真相。。。

冷血无情

我看到了重点，（昭）阳区

wuhuaguo54321

有没有具体内容呢

三尺之冰

没图你说毛线

sd2789390

我想知道CFDA会有什么动作呢！

kslam

FDA 6640 Import Alert

原因: 不缴GDUFA设施费

julia朱玉姣

kslam 发表于 2016-5-3 13:50
FDA 6640 Import Alert

原因: 不缴GDUFA设施费

66-40不是缴费原因，是不符合GMP

julia朱玉姣

Import Alert # 66-40
Published Date: 04/29/2016
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"

Reason for Alert:
*** Foreign inspections of pharmaceutical manufacturers are being performed. Detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's).



Detention without physical examination may also be appropriate when FDA receives information concerning inspections conducted by foreign or other government authorities under a Memorandum of Understanding or other agreement that FDA concludes reveals conditions or practices warranting detention of either particular products or all products manufactured by a firm.



DWPE of such firms remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed, either by reinspection or submission of appropriate documentation to the responsible FDA Center. ***

kslam

julia朱玉姣 发表于 2016-5-3 17:48
Import Alert # 66-40
Published Date: 04/29/2016
Type: DWPE

警告信声明如果没有交费:


Your facility has been placed on a publicly available GDUFA facility arrears list for failure to pay required fees in fiscal years 2013, 2014, and 2015. Seelink to arrears list at: http://www.fda.gov/forindustry%20/userfees/genericdruguserfees/default.htm. Failure to correct these violations promptly may result in regulatory action, including but not limited to seizure or injunction without further notice. Your facility may also be placed on import alert such that any drug the facility manufactures will be refused admission into the United States.

julia朱玉姣

kslam 发表于 2016-5-3 18:00
警告信声明如果没有交费:

1.4月18号公布的拖欠清单中有若干中国工厂，但其它并未列在进口禁令中
2.拖欠费用的公司确实在警告信清单中有，但并未在进口禁令中看到过
3.进口禁令各编号均有其含义，并不是混在一起的

zhongruixin

julia朱玉姣 发表于 2016-5-3 22:09
1.4月18号公布的拖欠清单中有若干中国工厂，但其它并未列在进口禁令中
2.拖欠费用的公司确实在警告信清 ...

确实如此。欠费是常态。