印度LAXACHEM被FDA发布进口禁令

julia朱玉姣

消息来自：http://www.fda.gov/drugs/drugsafety/ucm511527.htm

UPDATE[8/15/2016]

FDA issues import alert for all drugsproduced by Laxachem Organics in India

FDA给印度LAXACHEMORGANIC所有药品签发进口禁令

TheU.S. Food and Drug Administration placed Laxachem Organics Pvt. Ltd.,Ahmednagar, Maharashtra, India, on importalert on August 11, 2016, for refusing to allow FDA investigators toinspect its facility. The import alert stops all Laxachem pharmaceuticalproducts from entering the United States legally.
美国FDA于2016年8月11日给印度LAXACHEMORGANICS公司签发了进口禁令，因为该公司拒绝FDA调查员检查其工厂。进口禁令禁止所有LAXACHEM的药品进入美国。
Laxachemwill remain on import alert until it has been fully inspected by FDA and foundto meet U.S. standards.
在LAXACHEM接受FDA检查并被认为符合美国标准之前，禁令将维持有效。
Laxachemmanufactures active pharmaceutical ingredient (API) for repackagers, labelers,and wholesale drug distributors, some of which sell API to manufacturingfacilities in the United States. According to Laxachem’sfile:///C:\Users\jzhu\AppData\Local\Temp\msohtmlclip1\01\clip_image001.png website,one of the drugs Laxachem manufactures is Docusate Sodium USP.
LAXACHEM为再包装商、重新标签商和药品批发商生产原料药，其中一些将原料药销售给美国的生产工厂。根据LAXACHEM的网站，LAXACHEM生产的其中一种药品为琥珀辛酯钠USP。
Companiesthat received API from Laxachem should not distribute the API or productscontaining the API to customers.
已经接收了LAXACHEM的原料药的公司不得将原料药或含有这些原料药的制剂销售给客户。
Underthe Federal Food, Drug and Cosmetic Act (FD&C Act), drugs, including APIs,made at a facility that denies, limits, or delays an FDA inspection areconsidered adulterated. The FD&C Act prohibits distribution of adulteratedproducts.
根据FDCA，药品，包括原料药如果是在一种拒绝、限制或拖延FDA检查的工厂生产的，则会被认为是掺假。FDCA禁止掺假药的销售。
Formore information, see FDAguidance for industry, Circumstances that Constitute Delaying, Denying,Limiting, or Refusing a Drug Inspection

更多信息，参见官网。

syhorchid

了解一下

kkkkkking

路过了解一下

一沙一叶

拒绝检查的都很牛

蓝雨~

晕倒，还有拒绝检查的厂商，牛

zysx01234

因为该公司拒绝FDA调查员检查其工厂。进口禁令禁止所有LAXACHEM的药品进入美国。

我很高兴

hxnbh

很高兴啊，给印度LAXACHEMORGANIC赞一个，很牛