Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2017-09-20.
At a glance
Inspections
4
Form 483s
1
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Sep 2017 – 20 Sep 2017 | Medical Devices & Rad Health | Clean | |
| 11 Aug 2010 | Not recorded | 483 | View 483 → |
| 7 Jun 2006 | Not recorded | Clean | |
| 30 Jan 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Aug 2010
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Kinh Q Mac
Investigators
FDA investigators tied to this site in the record.
Loretta Nemchik1 insp.
Kinh Q Mac1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(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 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Abbott Point Of Care Inc.'s 1 Form 483
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