FDA Facility Registration & Product Listing
Facility Registration
Product Listing
Biennial Renewal
Compliance Review
Get Your FDA Registration Right the First Time
FDA facility registration and product listing are mandatory steps for most companies selling food, drugs, dietary supplements, or medical devices in the United States. Errors, missed renewals, or incomplete listings can block your products from entering the US market.
We manage the full registration process — from DUNS setup and FDA account creation through product listing and biennial renewal — so your US market access stays protected.
- Foreign and domestic facility registration across all regulated categories
- Product listing for drugs, OTC products, and medical devices
- Biennial renewal management for food facilities
- US Agent designation support (required for foreign facilities)
Why Registration Errors Are Costly
- FDA can suspend registrations for inaccurate information
- Suspended facilities cannot legally import into the US
- Missed biennial renewal = automatic suspension
- Incorrect product listing delays market entry
- Wrong US Agent info blocks FDA communication
Who Needs to Register with FDA?
Food & Beverage
Domestic and foreign facilities that manufacture, process, pack, or hold food for US consumption must register under the Bioterrorism Act / FSMA.
Dietary Supplements
Supplement manufacturers and packers must register as food facilities. GMP compliance and product listing support available.
Drugs & OTC Products
Domestic and foreign drug establishments must register with FDA and list all marketed drug products (NDC listing).
Medical Devices
Device establishments must register annually and list all devices manufactured, distributed, or imported into the US.
Our Registration & Listing Services
Initial Registration
- DUNS number setup (if needed)
- FDA account creation & activation
- Facility registration form completion
- US Agent designation (where required)
Product Listing
- Drug product listing (NDC assignment)
- OTC drug listing support
- Device listing & 510(k) cross-reference
- Supplement category alignment
Renewal & Maintenance
- Biennial renewal (food facilities)
- Annual device establishment renewal
- Change of ownership or address updates
- Registration accuracy audit
Ready to Register Your Facility with FDA?
Frequently Asked Questions
Who is required to register with the FDA?
Domestic and foreign facilities that manufacture, process, pack, or hold food, drugs, dietary supplements, or medical devices for US sale are generally required to register with FDA. Requirements vary by product category.
What is biennial renewal for food facilities?
Food facility registrations must be renewed every two years (odd-numbered years, October 1–December 31). Failure to renew on time can result in suspension of registration, blocking your products from US sale.
Do I need a US Agent to register?
Foreign food and drug facilities must designate a US Agent as part of their FDA registration. The agent serves as the FDA's primary point of contact in the United States.
What is a DUNS number and do I need one?
A DUNS (Data Universal Numbering System) number is often required to create an FDA account for registration. We help you obtain one if you don't already have it.
How long does FDA registration take?
Initial registration can typically be completed within a few business days once all information is ready. We help prepare everything upfront to avoid delays or rejection.
