FDA Stories #009 — A German Pharmaceutical Company Forgot to Pay Their GDUFA Fee. Registration Suspended.

A coconut milk producer in Samut Prakan, Thailand, had been shipping canned coconut milk to the United States through a trading company in Bangkok. The FDA food facility registration was current. The labels had been reviewed. The FCE and SID filings were in place. By every measure, the facility was compliant.

Except for one thing no one was doing.

The missing filing

Every shipment of food entering the United States requires Prior Notice — a filing submitted to the FDA before the food arrives at the US port. The timing requirements are strict: no more than 30 days and no fewer than 8 hours before arrival by ocean vessel. The Prior Notice must include the product description, manufacturer, shipper, FDA registration number, and anticipated arrival information. Without Prior Notice, the FDA can refuse admission automatically under Section 801(m) of the FD&C Act.

The trading company in Bangkok had been handling the export logistics but assumed that Prior Notice was the US importer's responsibility. The US importer assumed the trading company or their customs broker was filing it. The customs broker assumed it was already done. Nobody was filing it.

Twelve containers of canned coconut milk — over a period of nine months — had entered the US without Prior Notice. Every single one of them should have been refused.

How they got lucky

The FDA's PREDICT system flags shipments without Prior Notice, but the system processes millions of entries. Some shipments without Prior Notice slip through, especially when the facility has a clean compliance history and the product is low-risk. The Thai producer's shipments had been released because the overall risk profile was low. But luck is not a compliance strategy. One random audit, one PREDICT flag, and the first detention would have triggered scrutiny of every previous shipment.

The fix

We established a clear Prior Notice filing process: the US importer's customs broker files Prior Notice through the ACE system for every shipment, with the manufacturer's FDA registration number and correct product codes. We provided the customs broker with a Prior Notice data sheet for the facility — a single document containing every data point needed for every filing. No more assumptions about who is responsible.

Prior Notice is not the manufacturer's direct obligation — it is typically filed by the importer or their customs broker. But if it is not filed, your product gets detained and your facility's compliance record is damaged. Make sure someone in your supply chain is filing it. If you are not sure, ask us. fdabridge.com/contact.