FDA Inspection
Novartis Pharma Stein AGNovartis Pharma Stein AG – FDA Inspection, May 19, 2026
Record Details
This FDA Inspection record concerns Novartis Pharma Stein AG, with an inspection on May 19, 2026, issued by the Office of Inspections and Investigations, covering biologics.
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ID · a633da96-4e8c-467f-bbb0-0fc11887d34d
Inspection Facts
- Inspection number
- 1319902
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Novartis Pharma Stein AG
13| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2023 | Not classified | Office of Inspections and Investigations | |
| December 6, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 4, 2018 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| 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 1230809 - 2023-11-20
- FDA Inspection 1192104 - 2022-12-06
- FDA Inspection 1073408 - 2018-12-04
- FDA Inspection 1071638 - 2018-09-21
- FDA Inspection 1025563 - 2017-08-24
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