FDA Inspection
Novartis Pharmaceuticals CorporationNovartis Pharmaceuticals Corporation – FDA Inspection, Aug 8, 2024
Record Details
This FDA Inspection record concerns Novartis Pharmaceuticals Corporation, with an inspection on August 8, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · d2f19248-2be2-424d-85b3-a50251928268
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1245942
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of Novartis Pharmaceuticals Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2026 | Not classified | New Jersey District Office | Human Cellular, Tissue, and Gene Therapies |
| December 9, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| August 21, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 7, 2017 | Not classified | New Jersey District Office |
Other documents for Novartis Pharmaceuticals Corporation
- FDA Inspection 1300144 - 2026-02-06
- FDA Inspection 1194474 - 2022-12-09
- FDA Inspection 1100101 - 2019-08-21
- FDA Inspection 1019194 - 2017-04-07
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