Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2018-12-12.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Dec 2018 | Medical Devices & Rad Health | Clean | |
| 7 Dec 2016 | Medical Devices & Rad Health | Clean | |
| 8 Jan 2013 – 5 Mar 2013 | Medical Devices & Rad Health | Clean | |
| 3 Sep 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Sep 2009
21 CFR 820.22
Quality audits - auditor independence
Cited by Jessica L Peterson, Miranda D Mcdonald
Investigators
FDA investigators tied to this site in the record.
Eric C Fox1 insp.
Edward E Lockwood1 insp.
Janete A Oliveira1 insp.
Jessica L Peterson1 insp.
Miranda D Mcdonald1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biomedical Devices of Kansas, LLC'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