KITE PHARMA, INC.
Form 483 issued June 16, 2017 · EL SEGUNDO, California
- Inspection
- Jun 12 – Jun 16, 2017
- Investigator
- Anna C. Newachem
- Observations
- 4
- Pages
- 3
- FEI number
- 3012583739
In short: On June 16, 2017, FDA issued a Form 483 with 4 observations to KITE PHARMA, INC. in EL SEGUNDO, California (FEI 3012583739) after an inspection that ran Jun 12 – Jun 16, 2017. The investigator was Anna C. Newachem. Most observations concern production and materials.
At a glance
Production and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not drafted, reviewed and approved by…
- 02
Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, are…
- 03
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 04
The responsibilities and procedures applicable to quality control unit…
This inspection in context
Anna C. Newachem
1 document · 2017
Cites 211.100 (written procedures; deviations) 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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KITE PHARMA, INC.?
FDA listed 4 observations on this Form 483, mostly about production, materials and quality system. The opening words of each observation are shown on this page.
Who inspected KITE PHARMA, INC.?
Anna C. Newachem is named on this Form 483, for the inspection of Jun 12 – Jun 16, 2017. Each investigator has a profile showing what they cite most.
When was KITE PHARMA, INC. inspected by FDA?
The inspection ran Jun 12 – Jun 16, 2017, and the Form 483 is dated June 16, 2017.
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.