FDA/DUNS REGISTRATION

Required for U.S. Entry

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Title 21 of the United States  (U.S.)  Code of Federal Regulations (C.F.R), Chapter I, Subchapter A, Part 1, Subpart H and Section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002  (Bioterrorism Act)  require that all domestic and foreign facilities that are engaged in the manufacturing/processing, packing, or holding of food for human or animal consumption, register with the U.S. Food and Drug Administration (FDA). Registration must occur: 01) before the facility begins to manufacture, process, pack, or hold food for consumption in the U.S., and 02) bi-annually thereafter. Bi-annual registration, also known as “renewal” registration, must be submitted to the FDA during the period beginning October 1 and ending December 31 of each even-numbered year (e.g. 2020). Facilities located outside of the United States must also designate a U.S. Agent for FDA communications.

 

To apply for FDA Registration or Renew your facility's Registration: simply download, complete, and return the above-linked FDA Registration Form. Upon receipt, United Safety Agents will register your facility with the United States Food and Drug Administration.

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Additionally, any facility (including foreign facilities) that is required to register with FDA must obtain a DUNS number. To check if your facility already has a DUNS, please visit fdadunslookup.com.

 

To acquire a DUNS: simply download, complete, and return the above-linked DUNS Application Form. Upon receipt, United Safety Agents will perform all actions necessary to acquire your facility's DUNS.

 

All contact information is considered confidential and will only be used to provide you with requested service.

FDA Registration & U.S. Agent service is annual. After initial term, an annual rate will apply.

Questions? Contact United Safety Agents.

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Questions about FDA Registration or Compliance?

We are here to help – please do not hesitate to reach out.

 Schedule a Time to speak with an FDA expert.

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