FDA Inspection
Novartis Gene Therapies, Inc.Novartis Gene Therapies, Inc. – FDA Inspection, Jun 16, 2021
Record Details
This FDA Inspection record concerns Novartis Gene Therapies, Inc., with an inspection on June 16, 2021, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 16, 2021
- Product Type
- Biologics
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ID · 13259416-d963-4c3e-9e31-3b3d50b8daf5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1144535
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 212.40(b)Written specifications - components
- 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
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Other FDA inspections of Novartis Gene Therapies, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 8, 2019 | Not classified | Chicago District Office |
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