FDA Inspection
Novartis Pharma Stein AGNovartis Pharma Stein AG – FDA Inspection, Dec 4, 2018
Record Details
This FDA Inspection record concerns Novartis Pharma Stein AG, with an inspection on December 4, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 3f2284e9-7b71-4b40-a3f0-ac4686b89e80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1073408
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Novartis Pharma Stein AG
13| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2026 | Not classified | Office of Inspections and Investigations | Human Cellular, Tissue, and Gene Therapies |
| November 20, 2023 | Not classified | Office of Inspections and Investigations | |
| December 6, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 21, 2018 | Not classified | Office of Inspections and Investigations | |
| August 24, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Novartis Pharma Stein AG
- FDA Inspection 1319902 - 2026-05-19
- FDA Inspection 1230809 - 2023-11-20
- FDA Inspection 1192104 - 2022-12-06
- FDA Inspection 1071638 - 2018-09-21
- FDA Inspection 1025563 - 2017-08-24
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