FDA Stories #003 — A Turkish Cosmetics Brand Discovered Their Moisturizer Was an Unregistered Drug

A specialty coffee roaster in Minas Gerais, Brazil, had been exporting to the US for two years through a small importer in Miami. The FDA registration was active. Shipments were clearing. No detentions. Everything appeared to be working.

Then the importer changed. The new importer ran a compliance check — something the first importer never did — and flagged an inconsistency that had been hiding in plain sight since day one.

The mismatch

The company's legal name on the Brazilian Receita Federal was 'Fazenda São Jorge Cafés Especiais Ltda.' The DUNS number issued by Dun & Bradstreet was registered under 'Fazenda Sao Jorge Cafe Ltda' — no accents, abbreviated, no 'Especiais.' The FDA food facility registration used 'São Jorge Coffee Estate' — an English marketing name that matched neither the legal name nor the DUNS record.

Three different names across three different systems. The FDA registration was technically invalid because the facility name did not match the DUNS record. The DUNS record was technically wrong because it did not match the legal entity name on the Brazilian corporate registration. Every shipment that had entered the US over the past two years had done so with a facility registration that could have been challenged at any time.

Why it matters

The FDA uses the DUNS number as the Unique Facility Identifier. If the name on the DUNS record does not match the name on the FDA registration, the registration can be flagged, and the PREDICT system can assign a higher risk score to incoming shipments. More importantly, when the FDA sends communications to the US Agent — inspection notices, inquiries, recall requests — they use the name on the registration. If that name does not match the legal entity, it creates confusion, delays, and potential enforcement complications that can spiral.

The fix

We corrected the DUNS record with Dun & Bradstreet to match the exact legal entity name from the Brazilian Receita Federal, including accents and the full company suffix. We waited for the DUNS update to propagate (7 business days). Then we updated the FDA food facility registration to match the corrected DUNS record exactly. One name. One identity. Across all systems.

The entire correction took 12 business days. The new importer accepted the updated registration and resumed orders.

The lesson

Your company name must be identical — character for character — across your DUNS record, your FDA registration, and your corporate documents. If you used a marketing name, a translation, or a shortened version when you registered, it is wrong and it needs to be fixed. Contact fdabridge.com/contact and we will audit your registrations for free.