Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-02-13.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Feb 2026 – 13 Feb 2026 | Human Drugs | Clean | |
| 8 Sep 2017 – 21 Sep 2017 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Sep 2017
21 CFR 361.1(c)(2)
Numerical votes not in the minutes of any RDRC meetings
Cited by Sandra S Saniga
21 Sep 2017
21 CFR 361.1(c)(3)
FDA research proposals not reported +30 subjects
Cited by Sandra S Saniga
Investigators
FDA investigators tied to this site in the record.
Dustin R Abaonza1 insp.
Sandra S Saniga1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 361.1(c)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 361.1(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 361.1(f)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 361.1(f)(5) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lawrence Berkeley National Laboratory IRB's 1 Form 483
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