KITE PHARMA, INC.
Form 483 issued August 20, 2019 · EL SEGUNDO, California
- Inspection
- Aug 12 – Aug 20, 2019
- Investigators
- Gene D. Arcy· Scott Ballard
- Observations
- 3
- Pages
- 2
- FEI number
- 3012583739
In short: On August 20, 2019, FDA issued a Form 483 with 3 observations to KITE PHARMA, INC. in EL SEGUNDO, California (FEI 3012583739) after an inspection that ran Aug 12 – Aug 20, 2019. The investigators were Gene D. Arcy and Scott Ballard. Most observations concern laboratory controls and biologics CGMP.
At a glance
Laboratory controls and biologics cgmp account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The accuracy of test methods…
- 02
Biological product deviations are not reported within the…
- 03
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Gene D. Arcy
16 documents · 2003–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmKITE PHARMA, INC. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KITE PHARMA, INC.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, biologics CGMP and production. The opening words of each observation are shown on this page.
Who inspected KITE PHARMA, INC.?
Gene D. Arcy and Scott Ballard are named on this Form 483, for the inspection of Aug 12 – Aug 20, 2019. Each investigator has a profile showing what they cite most.
When was KITE PHARMA, INC. inspected by FDA?
The inspection ran Aug 12 – Aug 20, 2019, and the Form 483 is dated August 20, 2019.
How do I get the full Form 483 for KITE PHARMA, INC.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.