Overview
- 6 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
1 Oct 2015
21 CFR 312.62(b)
Case history records- inadequate or inadequate
Cited by Jennifer C Adams, Jennifer C Johnson
1 Oct 2015
21 CFR 50.20
Circumstances of obtaining consent
Cited by Jennifer C Adams, Jennifer C Johnson
Inspected site
SPSanjeev Puri, Clinical InvestigatorRock Island, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.64(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 312.60 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.62(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.66 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.20 | 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