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Novartis D.O.O.

FDA Regulatory Profile

Novartis D.O.O. has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Novartis D.O.O." and its spelling variant "Novartis". Records filed under related names are not included; see Related names.

Latest inspection
Dec 9, 2025 · VAI

Newer recall under related name Novartis Pharmaceuticals Corporation: Aug 4, 2026, D-0746-2026.

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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
Inspections9Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Novartis D.O.O.: FDA inspections per year 2017: 1 inspections120172018: 0 inspections020182019: 0 inspections020192020: 1 inspections120202021: 0 inspections020212022: 1 inspections120222023: 1 inspections120232024: 1 inspections120242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202410000
202310000
202210000
202100000
202010000
201900000
201800000
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.

Recent FDA inspections

9 inspections from Aug 12, 2009 to Dec 9, 2025.

DateSiteProductClassificationFEI
Dec 9, 2025Ljubljana, SloveniaDrugsVoluntary Action Indicated (VAI)3013358387
Feb 9, 2024Ljubljana, SloveniaDrugsVoluntary Action Indicated (VAI)3013358387
Jan 25, 2023Ljubljana, SloveniaDrugsVoluntary Action Indicated (VAI)3013358387
Sep 21, 2022Menges, SloveniaDrugsNo Action Indicated (NAI)3002807470
Sep 11, 2020Menges, SloveniaDrugsVoluntary Action Indicated (VAI)3002807470
Feb 13, 2017Menges, SloveniaDrugsNo Action Indicated (NAI)3002807470
Sep 18, 2015Menges, SloveniaDrugsNo Action Indicated (NAI)3002807470
Oct 19, 2012Menges, SloveniaDrugsNo Action Indicated (NAI)3002807470
Aug 12, 2009Menges, SloveniaDrugsNo Action Indicated (NAI)3002807470
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

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3013358387Ljubljana, Slovenia3Dec 9, 2025
FEI 3002807470Menges, Slovenia6Sep 21, 2022

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FDA data resources

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