Overview
- 19 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-01-27.
At a glance
Inspections
19
Form 483s
8
EIRs
9
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jan 2023 – 27 Jan 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Feb 2021 – 19 Feb 2021 | Medical Devices & Rad Health | Clean | |
| 26 Aug 2019 – 29 Aug 2019 | Medical Devices & Rad Health | Clean | |
| 9 Jul 2019 – 10 Jul 2019 | Medical Devices & Rad Health | Clean | |
| 17 Sep 2018 – 20 Sep 2018 | Medical Devices & Rad Health | Clean | |
| 3 Oct 2017 – 6 Oct 2017 | Medical Devices & Rad Health | Clean | |
| 1 May 2017 – 4 May 2017 | Medical Devices & Rad Health | Clean | |
| 19 Jan 2016 – 3 Feb 2016 | Medical Devices & Rad Health | Clean | |
| 23 Jun 2014 – 11 Jul 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Feb 2013 – 21 Feb 2013 | Medical Devices & Rad Health | Clean | |
| 11 Jul 2012 | Not recorded | 483 | View 483 → |
| 1 Jun 2011 | Not recorded | 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.
Jesse A Vazquez2 insp.
James W Plucinski2 insp.
Shafiq Ahadi1 insp.
MDSAP harperd1 insp.
Nicholas Z Lu1 insp.
Kathleen B Swat1 insp.
MDSAP WilliamsA1 insp.
David J Gasparovich1 insp.
That Q Dang1 insp.
Paola S Barnett1 insp.
Andrew A Leboeuf1 insp.
Joseph A Morkunas1 insp.
Lequita M Mayhew1 insp.
Christopher D Leach1 insp.
Nicole S Williams1 insp.
Brian D Nicholson1 insp.
Susan D Yuscius1 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 |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Abbott Molecular, Inc.'s 8 Form 483s
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