Seven Seas International USA LLC FDA Record

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

  • 3 Class I recalls
  • No warning letters matched by name
Inspections 0 0 OAI
Recalls 3 3 Class I (100%)
Warning letters 0 None on file
510(k) clearances 0 None on file

Seven Seas International USA LLC has 3 FDA recalls (3 Class I), 0 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Seven Seas International USA LLC" is on file.

What these totals cover: FDA records filed under the name "Seven Seas International USA LLC" and its spelling variant "Seven Seas International Usa".

Latest recall
F-0708-2023 · Class I · Mar 13, 2023

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls3 (3 Class I)Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections0Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Seven Seas International USA LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Seven Seas International USA LLC: FDA recall records per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202300011
202200011
202100000
202000000
201900011
201800000
201700000

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

3 recall records from May 6, 2019 to Mar 13, 2023.

NumberClassProductDate
F-0708-2023Class IBiltmore Smoked Sockeye Salmon - 4 ozMar 13, 2023
F-0173-2023Class IWild caught Alaskan Sockeye Smoked Salmon NET WT 4 OZ (113g) EXPIRATION DATE 7-11-2024 UPC…Nov 7, 2022
F-1426-2019Class IBiltmore, Sashimi Grade Smoked Wild Sockeye All Natural Alaskan Salmon, 4 oz. (113g)May 6, 2019

Seven Seas International USA LLC and the FDA: common questions

Has Seven Seas International USA LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Seven Seas International USA 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 Seven Seas International USA LLC received an FDA Form 483?

FDA has not published a Form 483 for "Seven Seas International USA LLC" in its reading room. FDA publishes some Form 483s, not all of them.

Has Seven Seas International USA LLC had an FDA recall?

Yes. Seven Seas International USA LLC has 3 FDA recalls on record, 3 of them Class I, the most serious class. The most recent started Mar 13, 2023.

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