Overview
- 15 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-28.
At a glance
Inspections
15
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Jun 2023 – 28 Jun 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jan 2020 – 17 Jan 2020 | Medical Devices & Rad Health | Clean | |
| 22 Jul 2019 – 2 Aug 2019 | Medical Devices & Rad Health | 483 | On file |
| 7 Feb 2017 – 17 Feb 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Mar 2016 – 24 Mar 2016 | Medical Devices & Rad Health | Clean | |
| 17 Nov 2015 – 24 Nov 2015 | Medical Devices & Rad Health | Clean | |
| 6 Apr 2015 – 9 Apr 2015 | Medical Devices & Rad Health | Clean | |
| 7 Apr 2014 – 11 Apr 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Jul 2013 – 1 Aug 2013 | Medical Devices & Rad Health | Clean | |
| 17 Oct 2012 | Not recorded | 483 | On file |
| 4 May 2012 | Not recorded | Clean | |
| 20 Sep 2011 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Jun 2023
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Janet Pulver, Kenya Destin
Investigators
FDA investigators tied to this site in the record.
James R Fleckenstein5 insp.
Leonard H Lavi3 insp.
Juanita Banuelos2 insp.
Janet Pulver1 insp.
Kenya Destin1 insp.
Thea C Grome1 insp.
Nicole M Gillette1 insp.
Alford R Taylor1 insp.
Uttaniti Limchumroon1 insp.
Sean T Creighton1 insp.
Kelvin Cheung1 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 | 4x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(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 803.50(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Abbott Medical's 6 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