Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-12-16.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Dec 2015 – 16 Dec 2015 | Medical Devices & Rad Health | Clean | |
| 18 Jan 2011 | Not recorded | 483 | View 483 → |
| 19 Mar 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Jan 2011
21 CFR 812.100
Investigator non-compliance with agreement/plan/regulations
Cited by Bryce E Mansfield, Graham N Giesen
18 Jan 2011
21 CFR 812.140(a)(2)(i)
Investigator device accountability inadequate
Cited by Bryce E Mansfield, Graham N Giesen
18 Jan 2011
21 CFR 812.150(a)(4)
No approval for investigator change in non-emergency
Cited by Bryce E Mansfield, Graham N Giesen
18 Jan 2011
21 CFR 812.150(a)(7)
Investigator report in response to a request
Cited by Bryce E Mansfield, Graham N Giesen
Investigators
FDA investigators tied to this site in the record.
Vanessa Y Jacobs1 insp.
Nichole A Broadhacker1 insp.
Bryce E Mansfield1 insp.
Graham N Giesen1 insp.
Lori J Silverstein1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 812.140(a)(2)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 50.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.100 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.150(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.150(a)(7) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Thomas K. Jones, MD -- Clinical Investigator's 2 Form 483s
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