KITE PHARMA, INC.
Form 483 issued October 22, 2021 · EL SEGUNDO, California
- Inspection
- Oct 14 – Oct 22, 2021
- Observations
- 2
- Pages
- 3
- FEI number
- 3012583739
In short: On October 22, 2021, FDA issued a Form 483 with 2 observations to KITE PHARMA, INC. in EL SEGUNDO, California (FEI 3012583739) after an inspection that ran Oct 14 – Oct 22, 2021. Most observations concern facilities & equipment and biologics CGMP; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and biologics cgmp account for 2 of 2 observations.
Most cited: 21 CFR 211.42(c)(10)(iv) (1×) · 600.80(c)(1)(ii) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Regarding the follow up of adverse experiences, investigations…
This inspection in context
Questions about this 483
What did FDA find at KITE PHARMA, INC.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and biologics CGMP. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
When was KITE PHARMA, INC. inspected by FDA?
The inspection ran Oct 14 – Oct 22, 2021, and the Form 483 is dated October 22, 2021.
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.