FDAストーリー #005 — パキスタンの米工場が存在しないFDA登録に$2,400を支払った

A spice processor in Kochi, India, had been exporting turmeric, black pepper, and chili powder to the United States for three years. Clean record. No detentions. No import alerts. A textbook export operation.

Then FDA tried to contact the facility's US Agent about a routine inquiry. The phone number on file went to voicemail. The FDA left a message. No one returned the call. The FDA tried again three days later. Voicemail again. No callback.

何が起きたか

The facility's US Agent was a one-person operation — someone the factory owner had found on a freelance platform. The agent had taken the $150 annual fee, listed their personal cell phone in the FDA system, and then stopped answering calls from numbers they didn't recognize.

When the FDA cannot reach the US Agent, it does not simply try again later. It flags the facility. The next shipment from that facility — a container of ground turmeric arriving in Newark — was held for examination. Not because the turmeric was contaminated. Not because the label was wrong. Because the FDA could not reach the US Agent, and that raised a compliance flag in the PREDICT system.

コスト

The turmeric shipment sat in a bonded warehouse in Newark for 11 days. The FDA requested documentation: the facility's food safety plan, HACCP records, and recent lab test results. The US Agent could not provide any of it because the US Agent had no relationship with the facility beyond collecting an annual fee. The importer had to scramble to get documents from India, translate them, and submit them to the FDA — all while demurrage charges accumulated.

Total cost of the detention: $4,200 in warehouse and demurrage fees, plus the importer's loss of confidence. The importer told the factory owner: find a real US Agent or I find a different supplier.

解決策

We took over as US Agent within 48 hours. We updated the FDA registration with our US-based contact information — a staffed phone line available during business hours, a monitored email, and a team that understands what the FDA is asking when they call. We also helped the facility organize its food safety documentation so that the next time FDA requests records, the response is immediate — not a two-week scramble.

Your US Agent is not a checkbox. It is the phone that rings when the FDA calls. If no one answers, everything downstream breaks. Visit fdabridge.com/contact to designate FDABridge as your US Agent.