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.
Scope of Work
FDA Food Facility Registration (Human and Animal Food)
- Review of client-provided information to determine registration applicability
- Electronic submission facilitation through FDA Industry Systems (FIS)
- Assistance with required attestations during submission
- Provision of registration confirmation and FDA registration number when issued
Optional add-on:
- One-time update/renewal submission facilitation assistance
U.S. Agent Representation (Foreign Facilities Only)
- Acceptance of designation as U.S. Agent in FDA registration
- Provision of U.S. Agent contact details for registration entry
- Receipt of FDA communications addressed to the U.S. Agent
- Forwarding of communications to the facility contact
Includes:
- Up to 2 hours/year standard communication coordination support
- Routing of inspection notices, inquiries, or emergency communications
Does not include drafting regulatory responses, corrective actions, or compliance consulting.
D-U-N-S® Number Registration Support
- Search for existing D-U-N-S® record status
- Data collection for D&B record alignment
- Facilitation of new registration submission if required
- Assistance correcting or updating inconsistent records
- Confirmation of issuance or validation when available
Issuance and acceptance are determined solely by Dun & Bradstreet and applicable authorities.
Administrative Coordination
- Alignment of facility identification details across submissions
- Delivery of confirmation records generated by submitting authorities
- Instructions for maintaining registration records
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
- FDA Registration submission confirmation
- FDA Registration Number (when issued)
- U.S. Agent designation confirmation
- Forwarded FDA communications (if received)
- D-U-N-S® confirmation or validation notice (if issued)
• 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
| Package | Fee (USD) | Action |
|---|---|---|
| FDA Food Facility Registration Assistance – Initial Registration | $250.00 (one-time) | Purchase |
| FDA Food Facility Registration Assistance – Annual Renewal/Updates Subscription | $199.00 / year | Subscribe |
| D-U-N-S® Registration Assistance | $200.00 (one-time) | Purchase |
| U.S. Agent Representation | $199.00 / year | 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 facilities required to appoint a U.S. Agent
- Businesses completing FDA facility identification requirements
- Companies needing a D-U-N-S® number for FDA registration
- Firms establishing initial FDA registration records
• 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 or import authorization
- Clients remain responsible for regulatory compliance and responding to FDA findings
- Services are limited to administrative facilitation and communication forwarding
- Regulatory outcomes and admissibility decisions are determined by 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
