FDA Facility Registration + U.S. Agent Representation + D-U-N-S® Registration + FSVP Agent Basic Service
Based on: 21 CFR 1.225–1.241, 1.500–1.514, FSMA, Bioterrorism Act, and Related FDA/USDA Requirements
This all-inclusive, one-time setup service ensures your food facility is fully registered, represented, and compliant with FDA and USDA regulations for entry into the U.S. market. The package includes FDA Facility Registration, D-U-N-S® Number acquisition, U.S. Agent Representation, and FSVP Agent Basic Service—covering core elements of FDA importer compliance under the FSMA rule.
Scope of Work
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 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).
• FSVP Agent Basic Support – First-year coverage for 1 supplier under FSVP.
Fees and Subscriptions
Bundled Registration Packages
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 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
Additional Notes:
• 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
