Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2018-05-23.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 May 2018 – 23 May 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Aug 2014 – 5 Aug 2014 | Medical Devices & Rad Health | Clean | |
| 9 Aug 2012 | Not recorded | Clean | |
| 30 Apr 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 May 2018
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Joseph R Strelnik
23 May 2018
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Joseph R Strelnik
Investigators
FDA investigators tied to this site in the record.
Joseph R Strelnik1 insp.
Cynthia A Harris1 insp.
Eric E Joneson1 insp.
Tracey L Siebesma1 insp.
Calvin K Cook1 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 820.50 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Advantis Medical's 1 Form 483
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