Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-01-17.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Jan 2019 – 17 Jan 2019 | Human Drugs | Clean | |
| 26 Oct 2015 – 4 Nov 2015 | Human Drugs | 483 | View 483 → |
| 10 Sep 2013 – 19 Sep 2013 | Medical Devices & Rad Health | Clean | |
| 24 Aug 2012 | Not recorded | Clean | |
| 23 Sep 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Nov 2015
21 CFR 312.50
Ensuring compliance with plan and protocol
Cited by Betsy C Galliher, Tracy R Ball
Investigators
FDA investigators tied to this site in the record.
Betsy C Galliher2 insp.
Brandy D Brown1 insp.
Cynthia F Kleppinger1 insp.
Tracy R Ball1 insp.
Michelle D Haamid1 insp.
Barbara M Frazier1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Duke Clinical Research Institute'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