Company
SwitzerlandNovartis Pharma Stein AG, Stein Ag, Switzerland – FDA Inspections
Inspection records and compliance data for Novartis Pharma Stein AG in Stein Ag. 14 FDA inspections on record, 5 Form 483s, last inspected May 19, 2026.
Company Profile
This profile covers Novartis Pharma Stein AG based in Stein Ag, Switzerland.
FDA Inspection History
- FDA inspections
- 14
- OAI
- 0
- VAI
- 6
- NAI
- 4
- Unclassified
- 4
- Form 483s
- 5
- Warning letters
- 0
First inspected March 27, 2009. Last inspected May 19, 2026.
Most cited issue areas
- Procedures for sterile drug products2 inspections
- Backup data not assured as exact and complete1 inspection
- Buildings not maintained in good state of repair1 inspection
FDA inspections (14)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 19, 2026 | Not classified | Biologics · Human Cellular, Tissue, and Gene Therapies | 1319902 |
| November 20, 2023 | Not classified | Biologics | 1230809 |
| December 6, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1192104 |
| December 4, 2018 | VAI | Biologics · Vaccines and Allergenic Products | 1073408 |
| September 21, 2018 | Not classified | Human Drugs | 1071638 |
| August 24, 2017 | Not classified | Biologics | 1025563 |
| May 9, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1015468 |
| October 16, 2015 | VAI | Biologics · Vaccines and Allergenic Products | 947993 |
| May 1, 2015 | NAI | Human Drugs · Drug Quality Assurance | 924507 |
| March 25, 2014 | NAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 875305 |
| June 22, 2012 | VAI | Human Drugs · Drug Quality Assurance | 791807 |
| July 2, 2010 | VAI | Human Drugs · Drug Quality Assurance | 672681 |
| March 2, 2010 | NAI | Human Drugs · Drug Quality Assurance | 651947 |
| March 27, 2009 | NAI | Human Drugs · Drug Quality Assurance | 576923 |
FDA documents
People (6)
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Company Information
Name
Novartis Pharma Stein AG
FEI Number
3002653483
Address
Schaffhauserstrasse 101, Stein Ag, Switzerland
Country
Switzerland
ID: 06be1f01-8421-471e-9d38-475fef9a9c5b