FDA Express

FDA Compliance Services

Foreign or domestic, your FDA compliance in one place: food facility registration, US Agent, MoCRA cosmetics, labeling support, and consultation, with a client portal for renewals and updates.

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Our Services

  • Food facilities: FURLS registration, biennial renewals, and US Agent representation under 21 U.S.C. §350d.
  • Cosmetics: MoCRA-oriented facility and product workflows with the same specialist team.
  • Food & cosmetics labeling compliance and consultation.

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Food facility and cosmetics registration

Food facility registration

For manufacturers, packers, importers, and distributors of food meant for consumption in the United States, including when you sell indirectly.

  • FURLS registration with specialist review
  • US Agent service aligned with 21 U.S.C. §350d
  • DUNS guidance & Support
Register a food facility
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Cosmetics facility registration

List and manage cosmetic product obligations with the FDA using the same secure account and support team as our food clients.

  • Product and facility registration (MoCRA)
  • Labeling support - align with FDA guidelines
  • Consultation - stay compliant with changing regulations
Register a cosmetics facility
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How it works

Easy, guided process

  1. Fill out the Food Facility Registration form

    Complete our short guided form with your facility details.

  2. Choose a plan

    Pick the registration term and options that fit your business.

  3. We process your file and DUNS support

    We review your details and help you obtain a DUNS number if you do not already have one.

  4. We submit to the FDA

    Our team files your registration with the FDA and handles follow-up as needed.

  5. Receive confirmation and your FFRN

    You get FDA confirmation and your Food Facility Registration Number (FFRN).

FAQ

Answers before you commit

Any food facility manufacturing, packing, importing, or distributing food intended for consumption in the US must register with the FDA. Whether such food products are sold directly or indirectly, as long as said food products are intended for consumption in the United States, the facility is required to maintain an FDA registration, regardless of sale volume.

From submission of application to final certificate it may take 48 - 72 hours, though the majority of businesses see shorter waiting times. Faster than you thought, right?

We not only register your business with the FDA, we also provide our expert US Agent services! As part of our obligation to you, and to ensure full compliance with the FDA (21 U.S.C. § 350d), our experts maintain an open line of communication ready to receive any requests and notices, however rare, from the FDA. In the extremely rare event that a notice or request is received from the FDA, we will notify you of such request and forward any notices to you.

FDA registrations must be renewed between October 1 through December 31 of every even-numbered year, however, as part of our simplification of registration promise - we automatically re-register your business! As long as you are an active member with us at FDA Express, we will renew your registration as required. If you wish to renew your membership with FDA Express, please head into your account area to view your current status. We will remind you when your term is coming up!

All Questions & Answers

Contact

Talk to the team

Direct lines to our team, we usually reply within one business day.

Email:
help@fdaexpress.us
Phone:
+1 (317) 657-2391
WhatsApp:
+972 (54) 229-5099
Contact form
Send us a message

Schedule a consultation

Reserve a free 30-minute call to review your FDA registration or compliance questions with our team.

Book now

Ready when you are

Create an account, choose food or cosmetics, and complete registration checkout when you are ready.

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