Edesia WorldWide U.S. Agent Service

To register, NON-U.S. food facilities must designate a U.S. agent for FDA communications.

All registered non-U.S. food facilities must designate a U.S. Agent for FDA communications. The U.S. Agent serves a different function than your importer, customs broker, commercial distributor, or trade association. For example, importers acting as your U.S. Agent could make mistakes that may affect your ability to ship to the United States. FDA communicates through the U.S. Agent to schedule inspections and to alert you of other FDA matters.

Edesia WorldWideU.S. Agent service includes:

  • Registration Renewal: Mandatory Biennial FDA Food Facility Registration Renewal
  • Certificate of Registration: Certificates issued by Registrar Corp provide confirmation of your facility’s registration to industry
  • Registration Updates: Registrations must be updated within 60 days of a change in required information
  • Prior Notice: Three free Prior Notice filings each year for your exports to the USA
  • Detention Assistance: Communication with FDA on your behalf to seek the release of a detained shipment
  • Mock FDA Inspection: Onsite expert assistance at no charge except travel and lodging for a scheduled FDA inspection
  • DUNS Assistance: Obtain a DUNS number or update an existing DUNS record
  • FDA Compliance Monitoring: A unique system that continuously monitors your company’s FDA compliance status

 

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

U.S. FDA CITATION: 21 C.F.R. SECTIONS 1.225 – 1.243U.S.
FDA food facility registration is required for all facilities that manufacture, process, pack, or store food, beverages, or dietary supplements that may be consumed in the United States. Facilities located outside the United States must also designate a U.S. Agent for FDA communications.

Food facility registration with U.S. FDA

For NEW food facility registrations with U.S. FDA

Edesia WorldWide Regulatory Specialist will register your facility with FDA and mail you a Certificate of Registration issued by Edesia WorldWide.

For facilities located outside the United States, Edesia WorldWide will also act as your U.S. Agent for FDA Communications.