Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-11-06.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Nov 2019 – 6 Nov 2019 | Medical Devices & Rad Health | Clean | |
| 1 May 2018 – 3 May 2018 | Medical Devices & Rad Health | Clean | |
| 30 Mar 2015 – 9 Apr 2015 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Kirtida Patel1 insp.
Kevin N Tran1 insp.
Vanessa Y Jacobs1 insp.
Leonard H Lavi1 insp.
Angela Shepas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 812.140(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ivantis Inc'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