U.S. FDA Agent Service for Foreign Facilities
Regulatory Scope & Official Admissibility Overview
Under 21 CFR § 1.227 and federal law, any foreign facility engaged in the manufacturing, processing, packing, or holding of food, beverages, dietary supplements, medical devices, pharmaceuticals, or cosmetics for consumption in the U.S. MUST designate an official U.S. Agent physically located in the United States.
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.
- Official U.S. FDA Agent Representation
- Physical U.S. Commercial Address for FDA Records
- 24/7 Emergency Communications Channel with FDA
- Inspection Scheduling & Formal Notice Forwarding
- Official Certificate of U.S. Agent Appointment
- Complete U.S. FDA Agent Representation
- Prior Notice Confirmation & Import Tracking Support
- FDA Facility Registration Verification & Annual Updates
- Regular Regulatory Alert & Policy Change Bulletins
- Direct Assistance with FDA Import Clearance Inquiries
- Dedicated FDA Compliance Officer Assigned
- Comprehensive U.S. Agent Representation
- FDA Detention Defense & Notice of Action Advisory
- Import Alert Removal Guidance & Petition Review
- Mock FDA Inspection Readiness Audit Protocol
- Priority Senior Regulatory Attorney Consultation
Documents Required for Filing
Ensure smooth clearance and zero customs holds by preparing these mandatory trade and compliance records.
Foreign Facility Legal Name & Address
Physical plant location where goods are manufactured or packed.
DUNS / FEI Number
Data Universal Numbering System identifier or FDA Establishment Identifier.
Authorized Signatory Credentials
Contact details of facility owner or corporate compliance director.
Product Category Scope
Detailed list of food, cosmetic, medical, or dietary products produced.
Step-by-Step Filing & Clearance Workflow
A transparent procedure ensuring guaranteed electronic clearance without cargo delays.
Agent Consent
Compliance Globally provides official consent documentation to serve as your U.S. Agent.
FDA System Linking
Linking our physical U.S. credentials to your FDA FURLS / FDA Direct facility account.
Confirmation Verification
FDA electronic confirmation receipt and official certificate issuance.
Continuous Monitoring
24/7 management of all formal regulatory correspondence and inspection scheduling.
Frequently Asked Questions
Statutory regulations, tariff classification, and agency timelines explained.