FDA Facility Registration & Renewal Services
Regulatory Scope & Official Admissibility Overview
The U.S. Food, Drug, and Cosmetic Act (FD&C Act) requires domestic and foreign facilities that manufacture, process, pack, or hold regulated products to register with the FDA. Food facilities must also renew their registration biennially during even-numbered years (October 1 – December 31).
Need Immediate Filing Assistance?
Connect directly with our U.S. licensed customs & regulatory specialists for rapid document pre-audit and tariff classification.
Transparent Service Packages
Choose the compliance plan that aligns with your shipment volume and regulatory complexity. Zero hidden surcharges.
- Initial FDA Food Facility Registration (FFR)
- DUNS (Unique Facility Identifier – UFI) Verification
- FURLS Electronic Account Setup
- Official 11-Digit FDA Registration Number Issuance
- Official Certificate of Registration Delivered
- FDA Facility Registration + Biennial Renewal Filing
- Medical Device Establishment Registration Filing
- Facility Information & Product Category Amendments
- Annual Compliance Status Verification Check
- Dedicated FDA Registration Specialist
- Pharmaceutical / OTC Drug Establishment Registration
- National Drug Code (NDC) Labeler Code Request
- Structured Product Labeling (SPL) Submission
- Multi-Site Global Facility Coordination
- Priority Regulatory Compliance Support
Documents Required for Filing
Ensure smooth clearance and zero customs holds by preparing these mandatory trade and compliance records.
DUNS Number (UFI)
Mandatory Data Universal Numbering System identifier matching exact business name and address.
Physical Plant Address
Exact geographic manufacturing address (P.O. boxes strictly prohibited).
Emergency Contact Details
24-hour phone and email of authorized plant supervisor.
Product Category Codes
Specific food categories or device classifications handled at the facility.
Step-by-Step Filing & Clearance Workflow
A transparent procedure ensuring guaranteed electronic clearance without cargo delays.
DUNS Audit
We verify that your DUNS record matches your official corporate name and address exactly.
FURLS Submission
Compiling facility data and transmitting through official FDA FURLS portal.
U.S. Agent Verification
Coordinating mandatory electronic confirmation with your U.S. Agent.
Registration Number Issuance
Receiving valid 11-digit FDA registration number and issuing certificate.
Frequently Asked Questions
Statutory regulations, tariff classification, and agency timelines explained.