What the U.S. importer of record is on the hook for — separate from your own facility's obligations.
Exporters often assume compliance is entirely their responsibility, or entirely their buyer's. In reality, it splits:
These can be the same company or entirely different companies. What matters is that both sets of obligations are covered by someone — a shipment with a compliant exporter but a U.S. buyer who hasn't done their FSVP homework is still at risk.
No — the U.S. Agent is named by the foreign facility to receive FDA communications. The U.S. importer of record is the party bringing goods into the U.S. and carries FSVP responsibility. They're often different parties.
Yes — this is common. Whoever is listed as importer of record on the customs entry takes on FSVP responsibility for that shipment.
We'll map out exactly which obligations fall on you vs. your U.S. buyer.
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