FDA Inspection 1144535 — Novartis Gene Therapies, Inc.
The FDA completed an inspection of Novartis Gene Therapies, Inc. on Jun 16, 2021 in Libertyville, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 16, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Libertyville, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 17772 | 21 CFR 212.40(b) | Written specifications - components |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |