Food Facility Registration and D-U-N-S® Registration Services
Registration Assistance Based on Section 415 of the FD&C Act and 21 CFR Part 1 Subpart H
To assist domestic and foreign food facilities with obtaining and maintaining required FDA registration and facility identification records necessary for lawful participation in the U.S. food supply chain.
This service includes FDA Food Facility Registration assistance, FDA registration update and biennial renewal assistance, D-U-N-S® Number registration support, and U.S. Agent Representation for eligible foreign facilities.
All services are administrative and facilitative in nature and are performed using information provided by the client. Services do not transfer regulatory responsibility and do not constitute regulatory consulting, legal advice, compliance management, or regulatory approval.
This service includes FDA Food Facility Registration assistance, FDA registration update and biennial renewal assistance, D-U-N-S® Number registration support, and U.S. Agent Representation for eligible foreign facilities.
All services are administrative and facilitative in nature and are performed using information provided by the client. Services do not transfer regulatory responsibility and do not constitute regulatory consulting, legal advice, compliance management, or regulatory approval.
Scope of Work
FDA Food Facility Registration Assistance
Administrative assistance for FDA Food Facility Registration applicable to domestic and foreign facilities engaged in manufacturing, processing, packing, or holding human or animal food.
Includes:
Includes:
- Registration applicability review
- Collection and organization of facility registration information
- Electronic submission facilitation through FDA Industry Systems (FIS)
- Assistance with required attestations and confirmation steps
- FDA registration confirmation and registration number, when issued
- Registration update and biennial renewal facilitation, where applicable
U.S. Agent Representation (Foreign Facilities)
Included with active FDA Food Facility Registration subscription services for eligible foreign facilities.
Includes:
Includes:
- Acceptance of U.S. Agent designation
- Provision of U.S. Agent contact information for FDA registration records
- Receipt and forwarding of FDA communications
- Registration-related communication coordination
- Maintenance of U.S. Agent information during the active subscription period
- Up to 2 hours annual communication coordination support
D-U-N-S® Number Registration Assistance
Assistance obtaining or validating a D-U-N-S® Number for use as a Unique Facility Identifier (UFI) and related regulatory purposes.
Includes:
Includes:
- Existing D-U-N-S® Number lookup
- Collection and organization of registration information
- D-U-N-S® Number registration facilitation
- Submission monitoring
- Confirmation of issuance, when available
Administrative Coordination
Includes:
- Alignment of facility identification information across registration activities
- Coordination of registration-related submissions
- Delivery of registration confirmations and related records
- General registration maintenance guidance
Deliverables
- FDA Food Facility Registration Submission Confirmation
- FDA Registration Number (when issued)
- FDA Registration Update or Renewal Confirmation (where applicable)
- U.S. Agent Designation Confirmation (foreign facilities)
- D-U-N-S® Number Confirmation (when issued)
- Registration Records and Submission Confirmations
Fees and Subscriptions
FDA Registration Services
| Service | Fee (USD) | |
|---|---|---|
| FDA Food Facility Registration, Updates, Renewals, and U.S. Agent Representation | $199/year per facility | Subscribe |
- U.S. Agent Representation
- FDA registration update assistance
- Biennial renewal assistance
- FDA communication forwarding
D-U-N-S® Registration Services
| Service | Fee (USD) | |
|---|---|---|
| D-U-N-S® Number Registration Assistance | $50 one-time per facility | Purchase |
Bundled Registration Packages
| Package | Fee | |
|---|---|---|
| FDA Facility Registration + U.S. Agent Representation + D-U-N-S® Registration + Certificate |
|
Purchase |
Ideal For:
- Foreign manufacturers, processors, packers, and storage facilities requiring FDA registration and U.S. Agent Representation
- Domestic food facilities establishing FDA registration records
- Companies requiring a D-U-N-S® Number as a Unique Facility Identifier (UFI)
- Facilities requiring assistance with FDA registration updates and biennial renewals
Additional Notes
- FDA Food Facility Registration is required for facilities that manufacture, process, pack, or hold food for consumption in the United States.
- Foreign facilities must maintain an active FDA registration and designate a U.S. Agent.
- U.S. Agent Representation is included with the annual FDA Registration subscription for eligible foreign facilities.
- FDA registration does not constitute product approval, import authorization, or regulatory clearance.
- Clients remain responsible for regulatory compliance and responding to FDA communications, inspections, and enforcement actions.
- Regulatory outcomes, admissibility decisions, and registration acceptance are determined solely by regulatory authorities.
