FDA Inspection
Novartis Gene Therapies, Inc.FDA Inspection 1098391 - Novartis Gene Therapies, Inc. - August 02, 2019
Record Details
This FDA Inspection record concerns Novartis Gene Therapies, Inc., with an inspection on August 2, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 2, 2019
- Product Type
- Biologics
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ID · b248dcf9-f018-40c9-81cf-1316bcb9a3bf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1098391
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Enforcement
- Other Correspondence
FDA Citations
5- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Novartis Gene Therapies, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2021 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Novartis Gene Therapies, Inc.
- FDA Inspection 1155029 - 2021-08-27
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