FDA Inspection
Kite Pharma, Inc.Kite Pharma, Inc. – FDA Inspection, Aug 20, 2019
Record Details
This FDA Inspection record concerns Kite Pharma, Inc., with an inspection on August 20, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 76901832-4400-44b6-9915-b8aa6c598211
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100058
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 600.14(c)When to report
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Kite Pharma, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2025 | VAI | Los Angeles District Office | Human Cellular, Tissue, and Gene Therapies |
| October 22, 2021 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 16, 2017 | Not classified | Los Angeles District Office |
Other documents for Kite Pharma, Inc.
- FDA Inspection 1279894 - 2025-08-27
- FDA Inspection 1155166 - 2021-10-22
- FDA Inspection 1015808 - 2017-06-16
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