Overview
- 39 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-29.
At a glance
Inspections
39
Form 483s
10
EIRs
13
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 May 2024 – 29 May 2024 | Biologics | Clean | |
| 1 Oct 2019 – 4 Oct 2019 | Medical Devices & Rad Health | Clean | |
| 21 Mar 2019 – 29 Mar 2019 | Biologics | 483 | View 483 → |
| 9 Oct 2017 – 13 Oct 2017 | Medical Devices & Rad Health | Clean | |
| 6 Oct 2017 | Medical Devices & Rad Health | Clean | |
| 4 May 2017 – 12 May 2017 | Biologics | Clean | |
| 10 Jan 2017 – 2 Feb 2017 | Medical Devices & Rad Health | Clean | |
| 4 Aug 2015 – 11 Aug 2015 | Biologics | 483 | On file |
| 3 Feb 2014 – 14 Feb 2014 | Medical Devices & Rad Health | Clean | |
| 6 Aug 2013 – 15 Aug 2013 | Biologics | 483 | On file |
| 8 Nov 2011 | Not recorded | Clean | |
| 29 Jul 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Mar 2019
21 CFR 820.70(h)
Use and removal, Lack of or inadequate procedures
Cited by Gene D Arcy, Kathleen B Swat, Susan A Zullo
29 Mar 2019
21 CFR 820.70(e)
Contamination control, Lack of or inadequate procedures
Cited by Gene D Arcy, Kathleen B Swat, Susan A Zullo
29 Mar 2019
21 CFR 820.70(e)
Contamination control, Lack of or inadequate procedures
Cited by Gene D Arcy, Kathleen B Swat, Susan A Zullo
29 Mar 2019
21 CFR 820.70(h)
Use and removal, Lack of or inadequate procedures
Cited by Gene D Arcy, Kathleen B Swat, Susan A Zullo
Investigators
FDA investigators tied to this site in the record.
James W Plucinski4 insp.
MDSAP harperd3 insp.
Russell K Riley3 insp.
Joseph A Morkunas3 insp.
Gene D Arcy2 insp.
Margaret Torres-Vazquez2 insp.
Creighton T Tuzon1 insp.
Kathleen B Swat1 insp.
Susan A Zullo1 insp.
Guang Gao1 insp.
Amanda Dinaro1 insp.
Jesse A Vazquez1 insp.
Prabhu P Raju1 insp.
Rafael Padilla1 insp.
Omotunde O Osunsanmi1 insp.
Susan M Jackson1 insp.
Helen B Ricalde1 insp.
Julie D Bringger1 insp.
Michael D Robinson1 insp.
Brian D Nicholson1 insp.
Nicole S Williams1 insp.
Amanda S Zorn1 insp.
Martha T Olone1 insp.
Sarah B Tanksley1 insp.
Kimberly Lewandowski-Walker1 insp.
Karen E Masley-Joseph1 insp.
Carrie-Ann Plucinski1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(h) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Abbott Laboratories' 10 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