Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-04-20.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Apr 2023 – 20 Apr 2023 | Medical Devices & Rad Health | Clean | |
| 24 Oct 2019 – 30 Oct 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Jul 2015 – 16 Jul 2015 | Medical Devices & Rad Health | Clean | |
| 8 Jun 2011 | Not recorded | Clean | |
| 9 Mar 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Oct 2019
21 CFR 820.30(c)
Design input - Lack of or inadequate procedures
Cited by Jenny L Mccardell
Investigators
FDA investigators tied to this site in the record.
Jenny L Mccardell2 insp.
Jenny L Chisem1 insp.
Sarah A Hassas1 insp.
Yvette E Guillermo1 insp.
Cntrctmntr Anderson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Statrad, 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