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Facility profile

Novartis Pharma Stein AG

Testing & analysis · Drug product manufacturing · Stein · Switzerland

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed20 registered company locations
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

AnalysisActive pharmaceutical ingredient (API) manufactureLabelManufacturePack
Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Dec 6, 2022 · FDA documented observations for voluntary correction.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

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Shows

Registration status and a latest matched voluntary action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Method and source details
View full inspection and compliance history11 inspection records

FDA inspection history

11 records, Mar 2009 – Dec 2022 · 5 NAI · 6 VAI · 0 OAI

DateClassProject areaCitationsFY
Dec 6, 2022VAIDrug Quality Assurance2023
Dec 4, 2018VAIVaccines and Allergenic ProductsYes2019
May 9, 2017VAIDrug Quality AssuranceYes2017
Oct 16, 2015VAIVaccines and Allergenic Products2016
May 1, 2015NAIDrug Quality Assurance2015
Mar 25, 2014NAIDrug Quality Assurance2014
Mar 25, 2014NAICompliance: Devices2014
Jun 22, 2012VAIDrug Quality Assurance2012
Jul 2, 2010VAIDrug Quality Assurance2010
Mar 2, 2010NAIDrug Quality Assurance2010
Mar 27, 2009NAIDrug Quality Assurance2009

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

No warning letter, injunction, or seizure is matched in the current data set.

Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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