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 • Includes FDA biennial registration and facility updates (ownership, location, or product changes) • 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) • Support for inspection notices, regulatory inquiries, and official FDA correspondence • First-year U.S. Agent representation included

USDA Establishment Registration (if applicable)

• Application support for USDA-registered facilities handling meat, poultry, or egg products • Guidance on USDA inspection readiness and compliance obligations

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 (for U.S. Importers)

• Assignment as your FSVP Agent for one facility or supplier under 21 CFR 1.500–1.514 • Maintenance of basic supplier documentation (FDA Registration, D-U-N-S®, HACCP/FSVP plan if available) • Support for FSVP identification during Prior Notice and Customs (ACE) filings • Response handling for basic FSVP verification inquiries from FDA

Product Jurisdiction Advisory

• Expert review of product types to determine FDA vs. USDA oversight • Advisory report outlining the appropriate regulatory pathway and agency registration

Registration Monitoring & Renewal Notifications

• Setup of proactive tracking for FDA biennial renewals and USDA periodic filings • Timely reminders to maintain compliance and avoid registration lapses

Deliverables

• FDA Facility Registration Confirmation • U.S. Agent Designation Letter (foreign facilities) • Optional Certificate of FDA Registration (for presentation use) • USDA Establishment Application (if applicable) • D-U-N-S® Number Confirmation (new or updated) • Facility Compliance Checklist • Product Classification & Jurisdiction Advisory Report • FSVP Agent Designation Confirmation (basic level) • Biennial Renewal and Compliance Monitoring Setup

Fees and Subscriptions

Bundled Registration Packages

Package	Fee (USD)	Action
FDA Facility Registration + U.S. Agent Representation + D-U-N-S® Registration + FSVP Agent Basic	$750.00 (one-time)	Subscribe
Renewal: FDA Registration + U.S. Agent + FSVP Agent Basic	$350.00 (annual)	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 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