FDA facility registration. Through the FURLS portal.
FDA requires facility registration for: food facilities (manufacturing, packaging, processing, storage of food consumed in US), drug establishments (manufacturers, repackagers, relabelers), cosmetic facilities (after MoCRA), and medical device establishments (manufacturers, specification developers, contract manufacturers). Registration through FURLS portal. Biennial renewal required. Foreign facilities also need US Agent. We register and manage renewals.
How we handle FDA Registration, end-to-end.
FDA requires facility registration for: food facilities (manufacturing, packaging, processing, storage of food consumed in US), drug establishments (manufacturers, repackagers, relabelers), cosmetic facilities (after MoCRA), and medical device establishments (manufacturers, specification developers, contract manufacturers).
Facility category
Food (FDA Food Facility Registration), drug (Drug Establishment Registration), cosmetic (MoCRA, since 2023), medical device (Device Establishment Registration). Each has different forms and requirements.
FURLS account + registration
Create FURLS (Food, Drug, Device Registration and Listings System) account. Complete category-specific registration. US Agent designation if foreign facility.
Product listings
Many categories require product listings (drug listing, device listing, cosmetic product listing). We coordinate listing in addition to facility registration.
Biennial renewal
All FDA registrations renew every 2 years. We track and refile. Lapse triggers FDA enforcement attention.
A clean handoff, in four steps.
You give us the basics. We handle the state, the IRS, and the compliance clock so you can focus on the business.
A name that's actually available.
Real-time check against the state register, USPTO trademark database, and matching domains.
Filed with the Secretary of State.
We submit your Articles, pay the state fee on your behalf, and return the stamped certificate.
EIN + the right tax setup.
Federal Employer ID with the IRS, plus state tax accounts when your business needs them.
Registered Agent + deadline tracking.
Your agent on file in every state, with every renewal and annual report tracked in one calendar.
Transparent fda registration pricing.
Government fees pass through at cost. No upsells.
Single facility
Initial registration for one facility, category-specific. FURLS account setup, registration submission, confirmation tracking. US Agent for foreign facilities additional $499/yr.
Get startedMulti-product listings
Facility registration plus product listings (drug listings, device listings, cosmetic product listings). For categories where product listings are required in addition to facility registration.
Get startedCompliance subscription
Annual subscription for ongoing FDA compliance: biennial renewal, listing updates, US Agent service (for foreign facilities), enforcement letter response.
Get startedAbout the FDA Registration Service.
Who needs FDA registration?
Is FDA registration free?
What is FURLS?
What about MoCRA?
What is a US Agent?
What is the biennial renewal?
Recommended add-ons
Most customers add these to keep their business compliant year-round.
Registered Agent
Most orderedRequired for every registered business entity in every state.
Compliance Monitoring
Best valueTrack every annual report, registered agent renewal, and license deadline.
Annual Report Filing
RecommendedAuto-file your state annual report. Never miss a deadline.
Premium compliance, no service-fee markup.
Trust you can verify
SOC 2 Type II audited platform. 220,000+ businesses served. 60-day money-back on service fees. State fees passed through at cost with no hidden markup. Explicit AUP on restricted industries.
A compliance partner, not a transaction
Most providers go quiet after checkout. We auto-track every annual report, registered agent renewal, and license deadline across your entities. The Business OS dashboard keeps your compliance score visible year-round.
Premium experience competitors cannot match
Premium positioning, transparent pricing, no service-fee markup on state or federal filings. Premium positioning, transparent pricing, no service-fee markup on state filings.