Food Facility Registration Services
Registration Program Implementation Based on 21 CFR 1.225–1.241, FSMA, and the Bioterrorism Act
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), in accordance with the Food Safety Modernization Act (FSMA) and the Bioterrorism Act.
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 FDA Food Facility Registration submission
- • Biennial FDA Registration Renewal (every even-numbered year)
- • U.S. Agent designation and representation for foreign facilities
- • Management of registration updates (e.g., facility name, address, ownership, product categories)
- • Support for maintaining active registration status and compliance
U.S. Agent Services for Foreign Facilities
Designate a qualified U.S. Agent in accordance with 21 CFR 1.232(d). The U.S. Agent serves as the official contact for FDA communications related to:
Includes:
- • Facility registration
- • Inspection notifications
- • Regulatory inquiries
- • Market access continuity
Registration Compliance Monitoring and Renewal Support
Provide ongoing support to monitor FDA registration status, proactively manage renewal periods, and assist with registration updates and compliance tasks.
Deliverables
• FDA Food Facility Registration or Biennial Renewal Confirmation
• U.S. Agent Designation Letter (for foreign facilities)
• Certificate of FDA Registration (optional, for client use)
• Facility Registration and Compliance Status Checklist
• Biennial Renewal and Monitoring Reminders
Fees and Subscriptions
FDA and USDA Registration Services
| Service | Fee (USD) |
|---|---|
| New FDA Food Facility Registration | $450 |
| Biennial FDA Registration Renewal | $350 |
| Certificate of FDA Registration | Included |
Pre-Requisites (Must Have)
• D-U-N-S Number
Ideal For:
• Foreign manufacturers, processors, packers, or holders of food, dietary supplements, pet food, or food contact materials exporting to the U.S.
• U.S.-based and International companies launching new food facilities requiring FDA registration
• Brand owners working with co-packers or contract manufacturers that must comply with FDA registration rules
• Foreign facilities needing active U.S. Agent representation for FDA compliance
• U.S.-based and International companies launching new food facilities requiring FDA registration
• Brand owners working with co-packers or contract manufacturers that must comply with FDA registration rules
• Foreign facilities needing active U.S. Agent representation for FDA compliance
Additional Notes
• FDA facility registration is mandatory for any facility that manufactures, processes, packs, or holds food for U.S. consumption.
• Registrations must be renewed biennially between October 1 and December 31 of even-numbered years.
• Foreign facilities must have a U.S. Agent designated at all times to maintain registration.
• Failure to register or renew may result in import refusals, shipment holds, or enforcement actions.
• Registrations must be renewed biennially between October 1 and December 31 of even-numbered years.
• Foreign facilities must have a U.S. Agent designated at all times to maintain registration.
• Failure to register or renew may result in import refusals, shipment holds, or enforcement actions.