Overview
- 9 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-03-27.
At a glance
Inspections
9
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Mar 2019 | Biologics | Clean | |
| 12 Oct 2017 | Medical Devices & Rad Health | Clean | |
| 24 Aug 2012 | Not recorded | 483 | View 483 → |
| 10 Mar 2011 | Not recorded | 483 | View 483 → |
| 27 Jul 2010 | Not recorded | Clean | |
| 14 Nov 2008 | Not recorded | Clean | |
| 27 Oct 2006 | Not recorded | Clean | |
| 13 Nov 2003 | Not recorded | Clean | |
| 18 Jan 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Aug 2012
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Nicole S Williams, Rafael Padilla
24 Aug 2012
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Nicole S Williams, Rafael Padilla
Investigators
FDA investigators tied to this site in the record.
Nicole S Williams2 insp.
Rafael Padilla2 insp.
Joseph A Morkunas2 insp.
Kathleen B Swat1 insp.
MDSAP harperd1 insp.
Jesse A Vazquez1 insp.
Amanda S Zorn1 insp.
Karen E Masley-Joseph1 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 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | 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 Laboratories Diagnostic Division's 2 Form 483s
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