FDA Inspection 1279894 — Kite Pharma, Inc.
The FDA completed an inspection of Kite Pharma, Inc. on Aug 27, 2025 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 27, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- El Segundo, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |