Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-10.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Aug 2024 – 10 Sep 2024 | Human Drugs | 483 | On file |
| 7 Aug 2017 – 10 Aug 2017 | Human Drugs | 483 | On file |
| 13 Jun 2011 | Not recorded | Clean | |
| 9 Mar 2006 | Not recorded | Clean | |
| 13 Sep 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Sep 2024
21 CFR 56.109(a)
Authority of the IRB
Cited by Kristin M Abaonza, Joan T Briones, Scott N Lim
10 Aug 2017
21 CFR 56.107(c)
One scientific and one non-scientific member
Cited by Dustin P Tran
10 Aug 2017
21 CFR 56.108(c)
Members present for review
Cited by Dustin P Tran
Investigators
FDA investigators tied to this site in the record.
Kristin M Abaonza1 insp.
Joan T Briones1 insp.
Scott N Lim1 insp.
Dustin P Tran1 insp.
Marie K Kinkade1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 56.107(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.109(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kaiser Foundation Research Institute IRB #8's 2 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat