Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2018-01-11.
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 |
|---|---|---|---|
| 10 Jan 2018 – 11 Jan 2018 | Medical Devices & Rad Health | Clean | |
| 22 Aug 2017 – 23 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 21 Jun 2012 | Not recorded | 483 | View 483 → |
| 14 Sep 2009 | Not recorded | Clean | |
| 8 Jul 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Sara M Richardson1 insp.
Maida Henesian1 insp.
CntrctMntr KingJ1 insp.
Joseph A Seitz1 insp.
Catherine J Laufmann1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Incisive Inc.'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