Food Facility and D-U-N-S® Registration Services
Registration Program Implementation Based on 21 CFR 1.225–1.241, FSMA, Bioterrorism Act, and Related Requirements
To assist and maintain compliance for U.S. and foreign food facilities, brand owners, and suppliers through proper registration with the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA) when applicable, and the establishment of a D-U-N-S® Number when required for verification, import entry, or regulatory identification purposes.
This service ensures lawful market entry, traceability readiness, and regulatory alignment for operations involving human food, animal food, dietary supplements, and food-related products.
Scope of Work
FDA Food Facility Registration (Human and Animal Food)
Register new domestic and foreign food facilities in accordance with 21 CFR 1.225–1.241 and FSMA. Includes initial registration, biennial renewal (every even-numbered year), U.S. Agent designation (for foreign facilities), and management of registration updates such as changes in facility address, ownership, or product categories.
U.S. Agent Services for Foreign Facilities
Assign a qualified U.S. Agent in compliance with 21 CFR 1.232(d). The U.S. Agent serves as the communication point between the foreign facility and the FDA for registration, inspections, and regulatory matters, ensuring uninterrupted market access.
USDA Establishment Registration (Meat, Poultry, Egg Products)
Prepare and coordinate applications for USDA establishment registration for facilities involved with meat, poultry, or processed egg products. Provide support for inspection readiness and USDA compliance requirements.
D-U-N-S® Number Registration Assistance
Assist domestic and foreign facilities in obtaining a D-U-N-S® (Data Universal Numbering System) Number through Dun & Bradstreet. The D-U-N-S® Number is used for facility identification by the FDA (especially for FSVP Importer Identification in ACE/Customs Filings) and may be required for supply-chain verification and import entry processes.
Includes:
- • D-U-N-S® Number Application Support
- • D-U-N-S® Data Update and Correction Support (if an existing D-U-N-S® Number needs updating for FDA recognition)
Registration Compliance Monitoring and Renewal Support
Monitor facility registration statuses to ensure compliance with renewal periods and regulatory update requirements. Provide proactive reminders for FDA Biennial Registration and USDA renewals, where applicable.
Product Jurisdiction Classification Advisory
Evaluate products to determine correct agency oversight (FDA or USDA) and ensure that proper registration and regulatory pathways are followed based on product type and business activity.
Deliverables
• FDA Food Facility Registration or Biennial Renewal Confirmation
• U.S. Agent Designation Letter (for foreign facilities)
• Certificate of FDA Registration (optional, for client presentation)
• USDA Establishment Application Package (if applicable)
• D-U-N-S® Number Confirmation (New Registration or Update)
• Facility Registration and Compliance Status Checklist
• Biennial Renewal and Monitoring Reminders
• Product Classification and Jurisdiction Advisory Report
Fees and Subscriptions
FDA and USDA Registration Services
| Service | Fee (USD) |
|---|---|
| New FDA Food Facility Registration | $450 |
| Biennial FDA Registration Renewal | $350 |
| U.S. Agent Service (Annual Fee) | $495 |
| Certificate of FDA Registration (Optional) | $150 |
| USDA Establishment Application Preparation | Custom Quotation (Starting at $950) |
D-U-N-S® Registration Services
| Service | Fee (USD) |
|---|---|
| D-U-N-S® Number Application or Update Assistance | $275 |
Bundled Registration Packages
| Package | Fee (USD) |
|---|---|
| FDA Facility Registration + U.S. Agent Service + D-U-N-S® Registration + Certificate | $1,195 (Save $175) |
Ideal For:
• Foreign manufacturers, processors, packers, or holders of food, dietary supplements, pet food, and food contact materials seeking entry into the U.S. market
• U.S.-based companies launching new food facilities or brands requiring FDA registration or USDA establishment registration
• Foreign suppliers needing U.S. Agent representation and D-U-N-S® Number registration for U.S. Customs and FDA compliance
• Brand owners working with third-party manufacturers or co-packers that must demonstrate registration compliance
Additional Notes
• FDA facility registration is a mandatory requirement for facilities producing, processing, packing, or holding food for consumption in the U.S.
• A D-U-N-S® Number may be required for FSVP Importer Identification Filing in U.S. Customs ACE systems.
• Foreign facilities must maintain an active FDA registration and have a designated U.S. Agent available at all times.
• Failure to maintain proper registration can lead to regulatory holds, shipment refusals, or import delays.