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Why FDA compliance is critical for your shipments to the U.S.

Every foreign manufacturer or distributor of food, cosmetics, drugs, or medical devices must register with the U.S. Food and Drug Administration.

Without proper registration, you risk:
- Shipment delays at customs
- Product holds or destruction
- Importer penalties

TABS ensures full compliance from day one, managing your registration, renewals, and communication directly with the FDA.

Complete FDA compliance management from registration to ongoing renewals

Expert guidance for every product category, from food to medical devices.

Food Facilities

FDA registration & bi-annual renewal
FSMA & FSVP guidance
FSVP agent/ importer services
Prior Notice filing

Cosmetics

Product & facility registration
Label & ingredient review for compliance

Drugs (Rx & OTC)

Establishment registration & annual renewal
Product listing & U.S. Agent assignment

Medical Devices

Device establishment registration & Listing
U.S. Agent representation

Not sure which category applies to you?

Book a 30-minute consultation with our FDA specialists (€75).
Understand FDA registration before you start

Understand FDA registration before you start

Get our free FDA Compliance Guide for European exporters. Learn how to register your facility, label products correctly, and meet U.S. import requirements.

Trusted FDA Agent for European Exporters

Official U.S. FDA Agent since 2014

Supporting 600+ European manufacturers and distributors

Clear, fixed-fee structure — no hidden renewals

Multilingual FDA specialists (English, Spanish, Dutch)

Offices in New York, Houston, Netherlands, and Spain

Trusted by international companies across every industry

Related Services

U.S. Market Entry

U.S. Business Address & Representation

Accounting & Tax Support

Ready to start your FDA registration?

We make your U.S. compliance simple, fast, and risk-free. Choose to buy directly or talk to our team first.

Ask us anything