Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-01-30.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Jan 2020 – 30 Jan 2020 | Medical Devices & Rad Health | Clean | |
| 8 Mar 2012 | Not recorded | Clean | |
| 24 Sep 2010 | Not recorded | 483 | View 483 → |
| 27 Jun 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Sep 2010
21 CFR 812.100
Investigator non-compliance with agreement/plan/regulations
Cited by Richard K Vogel
24 Sep 2010
21 CFR 812.110(b)
Investigator non-compliance with agreement/plan/regulations
Cited by Richard K Vogel
Investigators
FDA investigators tied to this site in the record.
Traci M Armand1 insp.
Gene R Gunn1 insp.
Lundy H Patrick1 insp.
Richard K Vogel1 insp.
Sonia M Monges1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 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 |
Full site report
Get the verbatim findings behind Feldman, Robert L, MD'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