FEI号申请流程

一、FEI号概况

FEI号：全称为“Facility Establishment Identifier”，通常译为“工厂识别号”，是FDA用来识别企业的独有号码。根据Federal Food, Drug, and Cosmetic Act 的section 510 和21 CFR part 207的规定，所有第一次从事药品的生产、制备、运输以及加工的企业需要进行注册（establishment registration），并提交所有已经上市销售产品信息（drug listing）。递交了establishment registration后，FDA会分派一个FEI 号 给企业。FDA也是按照这个FEI号来追查企业有没有及时交纳Drug establishment fee。

二、申请流程 

1）公司信息发给[e-mail]，收到如下回复

Dear ,Please contact the Electronic Drug Registration and Listing System to register your firm: [e-mail]

2）根据要求联系 [e-mail]后，回复如下：

The establishment registration SPL file needs to be submitted for this location in order to assign the FEI number. Please follow the guidance provided below for submitting registration and listing SPL files.

As of June 1, 2009, FDA no longer accepts paper submissions (forms 2656, 2657, 2658) for registration and listing. If you need to register and/or list with us or renew your existing registration or request a labeler code, you need to use the electronic system. For more instruction on the electronic registration and listing system visit: 

http://www./Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm078801.htm .

For the Gateway test account:

· If you have any questions/concerns relating to email policy, please contact [e-mail] and explain your situation.

· For Registration of Drug Establishment, your center is Office of the Commissioner (OC), not CDER.

· For the fastest service, please send all ESG technical support requests to [e-mail].

For technical assistance to prepare your SPLs:

Contact the SPL Coordinator at [e-mail]

Thank you,

eDRLS Team

dm

3）发送SPL文件后，收到回复

Please provide the name and address of the site location in question along with the Dunns number assigned to this site. The FEI number will be assigned once we’ve received the establishment registration SPL file by the import district office.

Thank you,

eDRLS Team

dm

4） 收到回复

Dear ,

Please see the FEI Number for XXXX below highlighted in red:

XXXXXXXXXXXXXX

三、SPL文件需要包含的内容：

厂家的名字和地址

厂家所用的所有商品名（trade names）

厂家的所有制类型（个人、合伙、公司）

厂家的拥有人(owner)或运营者(Operator)

境外厂家还需提供：

美国代理结构的名称、地址和电话号码；

进口商(importer)的名称（这个进口商可以是这个厂家的拥有者、委派人员或是厂家进口货物的接受者）；

出口商的名称；

如果之前还注册过其他厂房，在SPL文件中，还需要包含 之前注册过厂房的：

 官方联系人、电邮、电话和邮寄地址；

每个厂房是用来做什么的；

此外，SPL文件中还需要提供邓白氏号（DUNS number）；如果没有的话，FDA可安排申请者获得邓白氏号。