FDA Inspection
Novartis Pharmaceuticals CorporationNovartis Pharmaceuticals Corporation – FDA Inspection, Aug 21, 2019
Record Details
This FDA Inspection record concerns Novartis Pharmaceuticals Corporation, with an inspection on August 21, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · e4fab4a0-2d49-44f2-a6c8-f6170fd44cd2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100101
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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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 |
| August 8, 2024 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 9, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| April 7, 2017 | Not classified | New Jersey District Office |
Other documents for Novartis Pharmaceuticals Corporation
- FDA Inspection 1300144 - 2026-02-06
- FDA Inspection 1245942 - 2024-08-08
- FDA Inspection 1194474 - 2022-12-09
- FDA Inspection 1019194 - 2017-04-07
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