Home / Companies / Novartis Manufacturing NV

Novartis Manufacturing NV

FDA Regulatory Profile

Novartis Manufacturing NV has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Novartis Manufacturing NV" and its spelling variant "Novartis Manufacturing".

Latest inspection: Mar 5, 2025 · VAI

Reviewing Novartis Manufacturing NV as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Novartis Manufacturing NV yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Is this your company or a supplier you list? Link to this FDA record from your site with a free button.

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	7	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Novartis Manufacturing NV'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	2	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	1	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	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.

Recent FDA inspections

7 inspections from Jan 29, 2010 to Mar 5, 2025.

Date	Site	Product	Classification	FEI
Mar 5, 2025	Puurs-Sint-Amands, Belgium	Drugs	Voluntary Action Indicated (VAI)	3002037047
Mar 4, 2025	Indianapolis, IN	Drugs	Voluntary Action Indicated (VAI)	3019881323
Apr 29, 2021	Puurs-Sint-Amands, Belgium	Drugs	Voluntary Action Indicated (VAI)	3002037047
Nov 9, 2018	Puurs-Sint-Amands, Belgium	Drugs	Voluntary Action Indicated (VAI)	3002037047
Nov 15, 2016	Puurs-Sint-Amands, Belgium	Drugs	Voluntary Action Indicated (VAI)	3002037047
Mar 26, 2014	Puurs-Sint-Amands, Belgium	Drugs	No Action Indicated (NAI)	3002037047
Jan 29, 2010	Puurs-Sint-Amands, Belgium	Drugs	No Action Indicated (NAI)	3002037047

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 3002037047	Puurs-Sint-Amands, Belgium	6	Mar 5, 2025
FEI 3019881323	Indianapolis, IN	1	Mar 4, 2025

Need more than this page shows? Ask about Novartis Manufacturing NV in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.