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FDA Registration Information
October 10, 2003
In accordance with the Public Security and Bioterrorism Preparedness and Response Act of 2002, any foreign facility that "manufactures, processes, packs or holds food" must be registered with the FDA. In addition, any domestic facility that performs any of the above functions must be registered as well.
The following guideline is for reference as to who needs to register, however if there is any question if you or your supplier needs to register, it is best to do so.
M Manufacturer
P Processing
P Pack
H Hold
Registration Process:
The deadline for registration is December 12, 2003. Registration can be done on FDA form 3537 via mail or on the FDA
website: www. Fda.gov/furls
- Registrations will be accepted beginning Oct 16th.
- Foreign entities must appoint a U.S. agent to represent them. This can be an importer or customs broker as long as the agent maintains a place of business in the U.S.
- Registration is a one time process however any changes in the registrant's information must be reported within 60 days of the change.
- It is strongly recommended that a supplier provide their FDA registration number on any documentation for cargo being shipped to the U.S.
- Attempting to import cargo from a unregistered party, will result in the seizure and exam of your merchandise, with the possibility of criminal charges. This is why it imperative that you as an importer insure that your supplier is registered prior to the shipping of your goods.
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