Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2017-06-29.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Apr 2017 – 29 Jun 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Feb 2015 – 26 Feb 2015 | Medical Devices & Rad Health | Clean | |
| 20 Sep 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Jun 2017
21 CFR 812.110(b)
Investigator non-compliance with agreement/plan/regulations
Cited by Shalonda C Clifford
29 Jun 2017
21 CFR 812.140(a)(3)
Investigator's subject records inadequate
Cited by Shalonda C Clifford
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 812.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(a)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kraff, Colman R., M.D.'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