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Novartis Gene Therapies, Inc. FDA Record

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

Novartis Gene Therapies, Inc. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Novartis Gene Therapies, Inc." is on file.

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

Latest recall: D-0746-2026 · Aug 4, 2026 · filed under Novartis Pharmaceuticals Corporation
Latest inspection: Aug 27, 2021 · VAI

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

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	3	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Novartis Gene Therapies, Inc.'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	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	2	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	0	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.

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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 Gene Therapies, Inc. 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	Same company group	0	0	13	1	—
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 Innovative Technologies	Same company group	0	0	1	0	—

Recent FDA inspections

3 inspections from Aug 2, 2019 to Aug 27, 2021.

Date	Site	Product	Classification	FEI
Aug 27, 2021	San Diego, CA	Biologics	Voluntary Action Indicated (VAI)	3014617030
Jun 16, 2021	Libertyville, IL	Biologics	Voluntary Action Indicated (VAI)	3012983541
Aug 2, 2019	San Diego, CA	Biologics	Voluntary Action Indicated (VAI)	3014617030

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.

Facility	Location	Inspections	Latest
FEI 3014617030	San Diego, CA	2	Aug 27, 2021
FEI 3012983541	Libertyville, IL	1	Jun 16, 2021

Novartis Gene Therapies, Inc. and the FDA: common questions

Has Novartis Gene Therapies, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Novartis Gene Therapies, Inc." 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 Novartis Gene Therapies, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Novartis Gene Therapies, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Novartis Gene Therapies, Inc.?

The most recent FDA inspection on file ended Aug 27, 2021 at San Diego, CA and was classified VAI. FDA has 3 inspections of Novartis Gene Therapies, Inc. on file.

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