Overview
- 11 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2017-09-22.
At a glance
Inspections
11
Form 483s
1
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Sep 2017 – 22 Sep 2017 | Medical Devices & Rad Health | Clean | |
| 9 May 2016 – 11 May 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Oct 2014 – 31 Oct 2014 | Medical Devices & Rad Health | Clean | |
| 29 Jul 2013 – 1 Aug 2013 | Medical Devices & Rad Health | Clean | |
| 5 Apr 2012 | Not recorded | Clean | |
| 20 Oct 2011 | Not recorded | Clean | |
| 24 Jun 2011 | Not recorded | Clean | |
| 24 Nov 2009 | Not recorded | Clean | |
| 20 Oct 2009 | Not recorded | Clean | |
| 8 Sep 2008 | Not recorded | Clean | |
| 25 Jun 2007 | 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.
Diane C Van Leeuwen2 insp.
Trudy R Papson2 insp.
MDSAP WilliamsA1 insp.
Cynthia L Gorveatt1 insp.
Greg K Keshishyan1 insp.
Kimberly M Lichter1 insp.
Vashti E Bocker1 insp.
Marcus F Yambot1 insp.
Steven E Porter1 insp.
Brian P Putz1 insp.
Cntrctmntr Anderson1 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 | 2x |
Full site report
Get the verbatim findings behind Abbott Medical Optics Inc. (AMO)'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