FDA Facility Registration + U.S. Agent Representation + D-U-N-S® Registration
Based on 21 CFR 1.225–1.241 and related FDA registration requirements
This setup service assists a business or foreign food facility with completing required identification and contact elements needed before submitting FDA Food Facility Registration. The package includes FDA Food Facility Registration submission assistance, U.S. Agent designation, and DUNS Number registration support.
All services are administrative and facilitative in nature and are performed using information provided by the client. The services do not transfer regulatory responsibility and do not constitute compliance management, consulting, or regulatory approval.
All services are administrative and facilitative in nature and are performed using information provided by the client. The services do not transfer regulatory responsibility and do not constitute compliance management, consulting, or regulatory approval.
Scope of Work
D-U-N-S® Number Registration Assistance
Where required, assistance is provided to facilitate obtaining a D-U-N-S® Number for use as a Unique Facility Identifier (UFI).
Includes:
- Review of existing D-U-N-S® Number availability
- Collection and organization of business information required for registration
- Facilitation of D-U-N-S® Number application submission
- Monitoring of submission status
- Confirmation of D-U-N-S® Number issuance, when available
If an existing D-U-N-S® Number is identified, assistance may be provided to determine whether the available record reasonably aligns with the facility information intended for FDA registration.
Issuance, validation, acceptance, and usability of a D-U-N-S® Number are determined solely by Dun & Bradstreet and applicable regulatory authorities.
FDA Food Facility Registration Assistance
Administrative assistance for FDA Food Facility Registration in accordance with Section 415 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 1 Subpart H.
Includes:
- Review of client-provided information to determine registration applicability
- Collection and organization of facility registration information
- Facilitation of electronic submission through FDA Industry Systems (FIS)
- Assistance with required attestations and confirmation steps
- Provision of FDA registration confirmation and registration number when issued
- Registration cancellation assistance upon written client request
FDA Registration Updates and Biennial Renewals
Included as part of the active annual subscription.
Includes one-time facilitation per year for:
- FDA Food Facility Registration updates
- Biennial FDA Food Facility Registration renewals
- Collection and organization of renewal or update information
- Submission facilitation through FDA Industry Systems (FIS)
- Confirmation of submission activities, where applicable
Facilitation is performed using information provided by the facility and may require authorization or system access from the facility.
U.S. Agent Representation (Foreign Facilities Only)
For eligible foreign food facilities, U.S. Agent Representation is provided during the active subscription period.
Includes:
- Acceptance of designation as U.S. Agent
- Provision of U.S. Agent contact information for FDA registration records
- Receipt of FDA communications directed to the U.S. Agent
- Forwarding of FDA communications to facility contacts
- Coordination support relating to FDA registration communications
- Maintenance of U.S. Agent information during the active subscription period
Includes:
- Up to 2 hours per year of standard communication coordination support
- Routing of FDA inquiries, inspection notifications, and emergency communications
Does not include legal representation, regulatory consulting, inspection representation, preparation of regulatory responses, FSVP services, FSVPQI services, or PCQI services.
Administrative Coordination
- Alignment of facility identification information across registration activities
- Coordination of registration-related submissions
- Delivery of confirmation records generated by submitting authorities
- General registration maintenance instructions
FDA Food Facility Registration (Human and Animal Food)
• Registration of new domestic or foreign food facilities in accordance with 21 CFR 1.225–1.241, collecting and submitting facility information, processes and products, as well as information on facility ownership and emergency contacts
• First-year registration monitoring and maintenance included
U.S. Agent Services (for Foreign Facilities)
• Assignment of a qualified U.S. Agent for FDA communications per 21 CFR 1.232(d)
• Up to 2 hours/year of remote support and up to 5 email forwardings/year for inspection notices, regulatory inquiries, and official FDA correspondences
• First-year of U.S. Agent representation included
D-U-N-S® Number Registration Support
• Application submission for a new D-U-N-S® Number through Dun & Bradstreet
• Data correction and validation support for existing records used in FDA or ACE systems
FSVP Agent Basic Service
• Assignment as your FSVP Agent for one facility or supplier under 21 CFR 1.500–1.514
• Up to 2 hours/year of standard remote support and up to 5 email forwardings/year for FDA-initiated concerns
• Response handling for basic FSVP verification inquiries from FDA
Registration Monitoring & Renewal Notifications
• Setup of proactive tracking for FDA biennial renewals and periodic filings
• Timely reminders to maintain compliance and avoid registration lapses
Deliverables
- D-U-N-S® Number confirmation (when issued)
- FDA Food Facility Registration submission confirmation
- FDA Registration Number (when issued)
- FDA registration update or renewal submission confirmation, where applicable
- U.S. Agent designation confirmation
- Forwarded FDA communications, when received
• FDA Food Facility Registration & Confirmation – Complete registration with FDA and provide official confirmation.
• U.S. Agent Designation & Representation – First-year U.S. Agent services for foreign facilities.
• Certificate of FDA Registration – Issued after successful registration.
• D-U-N-S® Number Support & Confirmation – Assistance with new or updated D-U-N-S® registration.
• FDA Registration Monitoring – First-year monitoring to ensure ongoing compliance.
• Biennial Renewal & Compliance Setup – Preparation for FDA biennial renewal (if applicable).
Fees and Subscriptions
Bundled Registration Packages
| Service | Fee (USD) | Billing Frequency | Includes | Action |
|---|---|---|---|---|
| D-U-N-S® Number Registration Assistance | $50 USD | One-Time | D-U-N-S® Number registration facilitation, submission monitoring, and issuance confirmation assistance. | Purchase |
| FDA Food Facility Registration, Updates, Renewals, and U.S. Agent Representation | $199 USD | Annual (Per Facility) | FDA Food Facility Registration facilitation, FDA registration update assistance, biennial renewal assistance, U.S. Agent Representation (foreign facilities), FDA communication forwarding, and up to 2 hours annual coordination support. | Subscribe |
Includes:
• Initial FDA Food Facility Registration
• D-U-N-S® Registration Support
• First-Year U.S. Agent Representation
• First-Year FDA Registration Monitoring
• First-Year FSVP Agent Basic Support for 1 Supplier
Ideal For:
- Foreign food 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
• Foreign manufacturers and food-related facilities entering the U.S. market
• U.S.-based startups launching FDA-regulated food operations
• Importers needing FSVP identification and D-U-N-S® support
• Brand owners working with third-party processors or co-packers
Important Notes:
- FDA registration does not constitute product approval, import authorization, or regulatory clearance.
- D-U-N-S® Number issuance and acceptance are determined solely by Dun & Bradstreet and applicable authorities.
- Clients remain responsible for regulatory compliance and responding to FDA findings.
- Services are limited to administrative facilitation and communication coordination.
- Regulatory outcomes, admissibility decisions, inspections, and enforcement actions are determined solely by regulatory authorities.
• FDA registration is mandatory for facilities producing, packing, processing, or holding food for U.S. distribution
• D-U-N-S® Numbers are required for FSVP compliance and U.S. Customs (ACE) filings
• FSVP Agents are required for U.S. importers of foreign food suppliers
• This setup avoids regulatory delays, import refusals, and costly non-compliance penalties
