Fortune International, LLC DBA Fortune Fish & Gourmet LLC FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection NAI · Aug 19, 2026
  • No warning letters matched by name
Inspections 22 0 OAI
Recalls 1 0 Class I (0%)
Warning letters 0 None on file
510(k) clearances 0 None on file

Fortune International, LLC DBA Fortune Fish & Gourmet LLC has 1 FDA recall, 22 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Fortune International, LLC DBA Fortune Fish & Gourmet LLC" is on file.

What these totals cover: FDA records filed under the name "Fortune International, LLC DBA Fortune Fish & Gourmet LLC" and its spelling variants "Fortune International", "Fortune Fish And Gourmet", "Fortune International, Llc Dba Fortune Fish And Gourmet".

Latest recall
F-0208-2020 · Class II · Sep 12, 2019
Latest inspection
Aug 19, 2026 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls1Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections22Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Fortune International, LLC DBA Fortune Fish & Gourmet LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Fortune International, LLC DBA Fortune Fish & Gourmet LLC: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202520000
202410000
202300000
202210000
202110000
202010000
201900010
201800000
201720000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent recalls

1 recall record on Sep 12, 2019.

NumberClassProductDate
F-0208-2020Class IIFortune Fish & Gourmet fresh Atlantic salmon, whole, filleted, and filleted without belly sold by…Sep 12, 2019

Recent FDA inspections

22 inspections from Sep 15, 2009 to Aug 19, 2026. Showing the 20 most recent. View all 22 inspections

DateSiteProductClassificationFEI
Aug 19, 2026Riverside, MOFood/CosmeticsNo Action Indicated (NAI)3004465374
Aug 12, 2025Houston, TXFood/CosmeticsVoluntary Action Indicated (VAI)1000516235
May 21, 2025Riverside, MOFood/CosmeticsNo Action Indicated (NAI)3004465374
May 1, 2024Saint Louis, MOFood/CosmeticsNo Action Indicated (NAI)1931145
Jun 15, 2022Saint Louis, MOFood/CosmeticsNo Action Indicated (NAI)1931145
Aug 24, 2021Bensenville, ILFood/CosmeticsNo Action Indicated (NAI)3003408354
Feb 19, 2020Riverside, MOFood/CosmeticsNo Action Indicated (NAI)3004465374
Oct 26, 2017Saint Louis, MOFood/CosmeticsVoluntary Action Indicated (VAI)1931145
Jan 24, 2017Houston, TXFood/CosmeticsNo Action Indicated (NAI)1000516235
Dec 15, 2016Bensenville, ILFood/CosmeticsNo Action Indicated (NAI)3003408354
Feb 20, 2014Houston, TXFood/CosmeticsVoluntary Action Indicated (VAI)1000516235
Nov 7, 2013Riverside, MOFood/CosmeticsVoluntary Action Indicated (VAI)3004465374
Nov 6, 2013Bensenville, ILFood/CosmeticsVoluntary Action Indicated (VAI)3003408354
Apr 4, 2013Saint Louis, MOFood/CosmeticsNo Action Indicated (NAI)1931145
Sep 12, 2011Houston, TXFood/CosmeticsVoluntary Action Indicated (VAI)1000516235
Jul 20, 2011Bensenville, ILFood/CosmeticsVoluntary Action Indicated (VAI)3003408354
Jul 14, 2011Riverside, MOFood/CosmeticsVoluntary Action Indicated (VAI)3004465374
May 11, 2011Saint Louis, MOFood/CosmeticsVoluntary Action Indicated (VAI)1931145
Jan 25, 2011Houston, TXFood/CosmeticsVoluntary Action Indicated (VAI)1000516235
Oct 20, 2010Bensenville, ILFood/CosmeticsVoluntary Action Indicated (VAI)3003408354
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

4 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3004465374Riverside, MO5Aug 19, 2026
FEI 1000516235Houston, TX5Aug 12, 2025
FEI 1931145Saint Louis, MO6May 1, 2024
FEI 3003408354Bensenville, IL6Aug 24, 2021

Fortune International, LLC DBA Fortune Fish & Gourmet LLC and the FDA: common questions

Has Fortune International, LLC DBA Fortune Fish & Gourmet LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Fortune International, LLC DBA Fortune Fish & Gourmet LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Fortune International, LLC DBA Fortune Fish & Gourmet LLC received an FDA Form 483?

FDA has not published a Form 483 for "Fortune International, LLC DBA Fortune Fish & Gourmet LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Fortune International, LLC DBA Fortune Fish & Gourmet LLC?

The most recent FDA inspection on file ended Aug 19, 2026 at Riverside, MO and was classified NAI. FDA has 22 inspections of Fortune International, LLC DBA Fortune Fish & Gourmet LLC on file.

Has Fortune International, LLC DBA Fortune Fish & Gourmet LLC had an FDA recall?

Yes. Fortune International, LLC DBA Fortune Fish & Gourmet LLC has 1 FDA recall on record. The most recent started Sep 12, 2019.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.