Fermion Oy FDA Record

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

Fermion Oy has 0 FDA recalls, 15 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Fermion Oy" is on file.

What these totals cover: FDA records filed under the name "Fermion Oy" and its spelling variant "Fermion".

Latest inspection
Feb 25, 2026 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections15Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Fermion Oy's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Fermion Oy: FDA inspections per year 2017: 1 inspections120172018: 1 inspections120182019: 0 inspections020192020: 1 inspections120202021: 0 inspections020212022: 0 inspections020222023: 3 inspections320232024: 1 inspections120242025: 0 inspections020252026: 1 inspections12026
YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202500000
202410000
202330000
202200000
202100000
202010000
201900000
201810000
201710000

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 FDA inspections

15 inspections from Sep 29, 2010 to Feb 25, 2026.

DateSiteProductClassificationFEI
Feb 25, 2026Espoo, FinlandDrugsVoluntary Action Indicated (VAI)3003491490
Mar 14, 2024Hanko Pohjoinen, FinlandDrugsVoluntary Action Indicated (VAI)3002807817
Nov 24, 2023Espoo, FinlandDrugsVoluntary Action Indicated (VAI)3003491490
Mar 17, 2023Hanko Pohjoinen, FinlandDrugsVoluntary Action Indicated (VAI)3002807817
Jan 31, 2023Oulu, FinlandDrugsNo Action Indicated (NAI)3003340711
Feb 12, 2020Oulu, FinlandDrugsVoluntary Action Indicated (VAI)3003340711
Sep 14, 2018Hanko Pohjoinen, FinlandDrugsVoluntary Action Indicated (VAI)3002807817
Dec 8, 2017Oulu, FinlandDrugsVoluntary Action Indicated (VAI)3003340711
Jun 10, 2016Hanko Pohjoinen, FinlandDrugsVoluntary Action Indicated (VAI)3002807817
Jun 3, 2016Oulu, FinlandDrugsVoluntary Action Indicated (VAI)3003340711
Mar 14, 2014Hanko Pohjoinen, FinlandDrugsVoluntary Action Indicated (VAI)3002807817
Dec 13, 2013Oulu, FinlandDrugsNo Action Indicated (NAI)3003340711
Jun 17, 2011Espoo, FinlandDrugsNo Action Indicated (NAI)3003491490
Jun 16, 2011Hanko Pohjoinen, FinlandDrugsVoluntary Action Indicated (VAI)3002807817
Sep 29, 2010Oulu, FinlandDrugsVoluntary Action Indicated (VAI)3003340711
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

3 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3003491490Espoo, Finland3Feb 25, 2026
FEI 3002807817Hanko Pohjoinen, Finland6Mar 14, 2024
FEI 3003340711Oulu, Finland6Jan 31, 2023

Fermion Oy and the FDA: common questions

Has Fermion Oy received an FDA warning letter?

No FDA warning letter addressed to the name "Fermion Oy" 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 Fermion Oy received an FDA Form 483?

FDA has not published a Form 483 for "Fermion Oy" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Fermion Oy?

The most recent FDA inspection on file ended Feb 25, 2026 at Espoo, Finland and was classified VAI. FDA has 15 inspections of Fermion Oy on file.

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