Form FDA 483 Kite Pharma November 2024
Form 483 issued November 1, 2024 · Frederi ck, Maryland
- Inspection
- Oct 28 – Nov 1, 2024
- Investigators
- Lizaida Perez· Peng Zhou
- Observations
- 1
- Pages
- 3
In short: On November 1, 2024, FDA issued a Form 483 with 1 observation to Form FDA 483 Kite Pharma November 2024 in Frederi ck, Maryland after an inspection that ran Oct 28 – Nov 1, 2024. The investigators were Lizaida Perez and Peng Zhou. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 600.80 (postmarketing reporting of adverse experiences).
At a glance
1 of 1 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 600.80 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
All adverse experiences were not reported within 15 calendar day of initial…
This inspection in context
Lizaida Perez
2 documents · 2024–2026
Cites 600.80 (postmarketing reporting of adverse experiences) more than any other section. Most of their documents are for sites in California.
The firmForm FDA 483 Kite Pharma November 2024 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 600.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Form FDA 483 Kite Pharma November 2024?
FDA listed 1 observation on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 600.80 (postmarketing reporting of adverse experiences). The opening words of each observation are shown on this page.
Who inspected Form FDA 483 Kite Pharma November 2024?
Lizaida Perez and Peng Zhou are named on this Form 483, for the inspection of Oct 28 – Nov 1, 2024. Each investigator has a profile showing what they cite most.
When was Form FDA 483 Kite Pharma November 2024 inspected by FDA?
The inspection ran Oct 28 – Nov 1, 2024, and the Form 483 is dated November 1, 2024.
How do I get the full Form 483 for Form FDA 483 Kite Pharma November 2024?
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.