Overview
- 6 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
LBLawrence Berkeley National Laboratory IRBBerkeley, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| 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 483 report
Get the verbatim text of all 6 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere