What is a US FDA Agent?

A US FDA Agent is a legally required representative for foreign facilities that manufacture, process, pack, or hold FDA-regulated products. The agent must be physically located in the United States and serves as the official point of contact between the FDA and the foreign facility — receiving inspection notices, import alerts, and all FDA correspondence.

Does my company need FDA registration?

Yes, if your facility manufactures, processes, packs, or holds drugs, food, dietary supplements, cosmetics, or medical devices for the US market. FDA facility registration is required under the Bioterrorism Act (food), 21 CFR 207 (drugs), 21 CFR 807 (devices), and MoCRA (cosmetics). Products from unregistered facilities are considered adulterated and cannot legally enter the US.

What is MoCRA and does it apply to my cosmetic brand?

MoCRA (Modernization of Cosmetics Regulation Act) is a 2022 US law requiring cosmetic facility registration, product listing, Responsible Person designation, and serious adverse event reporting for all cosmetic brands sold in the US — including foreign brands. If your cosmetic products are sold in the United States, MoCRA applies to you regardless of where they are manufactured.

What is drug listing and why is it required?

Drug listing is the process of registering every drug product marketed in the US with the FDA through the Structured Product Labeling (SPL) system. Every drug must have an assigned NDC (National Drug Code) number and a current SPL submission on file. Drug listing is required under 21 CFR Part 207 and must be updated whenever labeling or formulation changes.

What is an NDC number?

An NDC (National Drug Code) is a unique 10-digit identifier assigned to every drug product marketed in the United States. The NDC consists of a labeler code (assigned by the FDA), a product code, and a package code. NDC numbers must appear on drug labels and are required for drug listing in the FDA's database.

How long does FDA compliance take for a foreign manufacturer?

Basic FDA compliance for a foreign manufacturer — including US Agent appointment, facility registration, and initial drug or product listing — can typically be completed in 5-15 business days with the right guidance. More complex pathways such as ANDA or NDA submissions require 12-24 months. Axentra provides a free 24-hour expert assessment of your specific compliance timeline.

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Frequently asked questions

FDA Pet Food Compliance FAQs

Cosmetovigilance Services FAQs

US Labeling Compliance Review FAQs

FDA Drug Listing & SPL Compliance FAQs

OTC Drug & Sunscreen FDA Registration FAQs

Food Facility Registration FAQs

Dietary Supplement Compliance FAQs

FDA Facility Registration FAQs

GENERAL FAQs

MoCRA Compliance for Cosmetics and OTC

RLD Sourcing & GDP Compliance

US Agent-Registration-Drug listing FAQs

FSVP I GMP I COMPLIANCE SUPPORT FAQs

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Frequently asked questions

What is AAFCO and does it approve pet food?

Do pet food facilities renew FDA registration on the same biennial schedule as human food?

What is 21 CFR Part 507 for animal food manufacturers?

Is Prior Notice required for pet food shipments into the United States?

Does the $299 starting fee include AAFCO label review and state feed registrations?