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Novartis Pharma AG

FDA Regulatory Profile

Novartis Pharma AG has 0 FDA recalls, 13 inspections, 0 510(k) clearances and 1 compliance action on record.

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

Latest inspection: Dec 18, 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
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	13	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	1	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	1	0	0	0	0
2017	1	0	0	0	0

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.

Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Novartis Pharma AG above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Novartis Pharmaceuticals Corporation Combines 2 spellings Novartis Pharmaceuticals: 26 recalls, 13 inspections Novartis Pharmaceuticals Corporation: 7 recalls, 41 inspections	Same company group	33	0	54	0	Aug 4, 2026 (D-0746-2026)
Advanced Accelerator Applications Usa	Same company group	4	0	5	0	Sep 23, 2024 (D-0007-2025)
Sandoz Incorporated	Same company group	16	0	8	1	Apr 6, 2018 (D-0631-2018)
Sandoz Nutrition	Same company group	0	20	0	0	—
Novartis Pharma Stein	Same company group	0	0	12	0	—
Novartis	Same company group	0	0	9	0	—
Advanced Accelerator Applications (Italy)	Same company group	0	0	8	0	—
Novartis Gene Therapies	Same company group	0	0	3	0	—
Novartis Innovative Technologies	Same company group	0	0	1	0	—

Recent FDA inspections

13 inspections from Nov 6, 2008 to Dec 18, 2025.

Date	Site	Product	Classification	FEI
Dec 18, 2025	Basel Town, Switzerland	Drugs	Voluntary Action Indicated (VAI)	3002807772
Jun 4, 2024	Basel, Switzerland	Drugs	No Action Indicated (NAI)	3014747778
Aug 30, 2022	Basel Town, Switzerland	Drugs	Voluntary Action Indicated (VAI)	3002807772
Jul 12, 2019	Basel Town, Switzerland	Drugs	No Action Indicated (NAI)	3002807772
Aug 24, 2018	Basel, Switzerland	Drugs	No Action Indicated (NAI)	3014747778
Jul 6, 2017	Basel Town, Switzerland	Drugs	Voluntary Action Indicated (VAI)	3002807772
Jan 14, 2015	Basel Town, Switzerland	Drugs	No Action Indicated (NAI)	3002807772
Dec 5, 2013	Basel Town, Switzerland	Drugs	No Action Indicated (NAI)	3002807772
Jul 26, 2012	Basel Town, Switzerland	Drugs	Voluntary Action Indicated (VAI)	3002807772
Jul 18, 2012	Basel Town, Switzerland	Drugs	No Action Indicated (NAI)	3002807772
Jun 8, 2012	Basel, Switzerland	Drugs	Voluntary Action Indicated (VAI)	3009487425
Nov 21, 2008	Basel Town, Switzerland	Drugs	Voluntary Action Indicated (VAI)	3002807772
Nov 6, 2008	Basel Town, Switzerland	Drugs	Voluntary Action Indicated (VAI)	3002807772

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Novartis Pharma AG: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Nov 18, 2011.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

3 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002807772	Basel Town, Switzerland	10	Dec 18, 2025
FEI 3014747778	Basel, Switzerland	2	Jun 4, 2024
FEI 3009487425	Basel, Switzerland	1	Jun 8, 2012

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