FDA Inspection 1100058 — Kite Pharma, Inc.
The FDA completed an inspection of Kite Pharma, Inc. on Aug 20, 2019 in El Segundo, CA. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 20, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- El Segundo, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 9089 | 21 CFR 600.14(c) | When to report |