Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-08-22.
At a glance
Inspections
7
Form 483s
4
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Aug 2019 – 22 Aug 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Apr 2018 – 25 Apr 2018 | Medical Devices & Rad Health | WL | View 483 → |
| 2 Sep 2014 – 10 Sep 2014 | Medical Devices & Rad Health | Clean | |
| 3 Apr 2012 | Not recorded | Clean | |
| 22 Dec 2010 | Not recorded | 483 | View 483 → |
| 8 Aug 2008 | Not recorded | 483 | On file |
| 21 Sep 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Aug 2019
21 CFR 820.198(d)
Evaluation, timeliness, identification
Cited by James A Lane, Eric J Heinze
22 Aug 2019
21 CFR 820.198(d)
Evaluation, timeliness, identification
Cited by James A Lane, Eric J Heinze
22 Aug 2019
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by James A Lane, Eric J Heinze
Investigators
FDA investigators tied to this site in the record.
James A Lane1 insp.
Eric J Heinze1 insp.
Seema S Singh1 insp.
Ian A Pilcher1 insp.
Joseph A Seitz1 insp.
Maida Henesian1 insp.
Linda S Shook1 insp.
Juan A Morales1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.180 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Abaxis Inc's 4 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