Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2018-06-21.
At a glance
Inspections
2
Form 483s
1
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Jun 2018 – 21 Jun 2018 | Human Drugs | Clean | |
| 25 Jan 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jan 2010
21 CFR 56.115(a)(1)
Copies of all research proposals and related documents
Cited by Nancy E Fontaine
Investigators
FDA investigators tied to this site in the record.
Brandy D Brown1 insp.
Nancy E Fontaine1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 56.108(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.109(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(5) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Trident Health System Irb's 1 Form 483
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