FDA Inspection 1253766 — Kite Pharma, Inc.
The FDA completed an inspection of Kite Pharma, Inc. on Nov 1, 2024 in Frederick, MD. 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 1, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Frederick, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 9095 | 21 CFR 600.80(c)(1)(i) | Reporting Requirements - 15-day alert |