Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-06.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Sep 2023 – 6 Sep 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Oct 2021 – 29 Oct 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Feb 2017 – 9 Feb 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Oct 2012 | Not recorded | 483 | View 483 → |
| 5 May 2009 | Not recorded | 483 | On file |
| 10 Aug 2006 | Not recorded | Clean | |
| 3 Dec 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Sep 2023
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Alex J Wild
6 Sep 2023
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Alex J Wild
Investigators
FDA investigators tied to this site in the record.
Alex J Wild1 insp.
Emma R Schaefer1 insp.
Lisa A Warner1 insp.
Joshua J Silvestri1 insp.
Bill Tackett1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 12x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 5 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