Situation

A U.S. importer had brought in a single container of kimchi from overseas for five years without incident.

Problem

A consumer who ate the kimchi was hospitalized with food poisoning; FDA traced the source and demanded FSVP records within 24 hours. All the importer had was a single sheet — the supplier's HACCP certificate.

Timeline

• Misconception 1 — 'I'm too small an importer for this to apply to me' (it applies regardless of size)
• Misconception 2 — 'It's fine as long as the manufacturer has a certificate' (a certificate alone isn't enough)
• Misconception 3 — 'Why would I do this if FDA's never asked' (five incident-free years isn't proof of safety)
• Misconception 4 — 'The Importer of Record will handle it' (the FSVP Importer has to be separately designated)

Losses