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HomeU.S. FDA Food Regulations › U.S. FDA Food Facility Registration and U.S. Agent

U.S. FDA Food Facility Registration and U.S. Agent Requirements

FDA Registration and U.S. Agent Requirement (Bioterrorism Act) U.S. FDA food facility registration is required for all companies that manufacture, process, pack, or store food, beverages, or dietary supplements that may be consumed in the United States. Companies located outside the United States must also designate a U.S. Agent for FDA communications.

The U.S. Agent for FDA communications serves a different function than an importer, customs broker or commercial distributor. FDA sends communications to the designated U.S. Agent, including information regarding inspections, often requiring an immediate response. Registrar Corp's Regulatory Specialists will handle a foreign facility's FDA communications professionally as a U.S. Agent.

As part of our U.S. Agent service, Registrar Corp's Regulatory Specialists will:

  • Renew your U.S. FDA Food Facility registration, properly.
  • Assist if your shipments to the U.S. are detained by FDA.
  • Dispatch a Food Safety Expert to conduct a Mock FDA Inspection of your facility in advance of a scheduled FDA inspection free of charge other than travel expenses.

    For NEW Food Facility Registrations with U.S. FDA

    Click the following link to register your food facility and obtain your Food Facility Certificate of Registration issued by Registrar Corp

    Register Your Food Facility with the U.S. FDA ››

    To RENEW Your Food Facility Registration with U.S. FDA

    The new U.S. FDA Food Safety Modernization Act (FSMA) requires food facilities to renew their FDA Food Facility Registrations between October 1, 2014 and December 31, 2014. Companies located outside the United States must also designate a U.S. Agent for FDA communications. Registrar Corp provides both services to assist you.

    Renew Your Food Facility Registration ››

    U.S. FDA Regulations:

    U.S. FDA Food Facility Registration: 21 C.F.R. sections 1.225 - 1.243


    Food Facility Registration
    Service Including Certificate:
    US$ 195/facility

    Food Facility U.S. Agent
    Annual Fee: US$ 495

    Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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