Canned Tuna — Building FSVP for a Product That Didn't Need It
Missed the §1.501 Exemption — Wasted Time, Wrong Direction
Situation
A canned-tuna importer built out FSVP from the ground up — hazard analysis, supplier evaluation, and verification activities — spending significant time and money.
Problem
Tuna is seafood, exempt from FSVP under §1.501, and instead requires compliance with 21 CFR §123.12 (seafood importer HACCP requirements). This company had no seafood HACCP plan under §123.12 — it built an FSVP file it didn't need while going into inspection without the HACCP plan it actually needed.
Timeline
- FSVP buildout completed — hazard analysis, supplier evaluation, verification plan all done
- FDA inspection — notes seafood is FSVP-exempt, demands a §123.12 seafood HACCP plan
- Afterward — new HACCP plan built under §123.12, taking 3 months
Losses
Time and money wasted building unnecessary FSVP3 months to build a new HACCP plan
📌 Check §1.501 exemption status before starting FSVP. Seafood falls under §123.12, juice under §120.14, instead.