Overview
- 7 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-09-01.
At a glance
Inspections
7
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Aug 2022 – 1 Sep 2022 | Medical Devices & Rad Health | Clean | |
| 16 Jun 2015 – 18 Jun 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Feb 2012 | Not recorded | Clean | |
| 28 May 2010 | Not recorded | Clean | |
| 20 Jun 2008 | Not recorded | Clean | |
| 5 Nov 2003 | Not recorded | Clean | |
| 26 Sep 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Jun 2015
21 CFR 820.75(b)(2)
Documentation of validated process performance
Cited by Andrew Saunders
18 Jun 2015
21 CFR 820.75(b)(2)
Documentation of validated process performance
Cited by Andrew Saunders
Investigators
FDA investigators tied to this site in the record.
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 820.75(b)(2) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind AngioSystems 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