Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-01-30.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jan 2023 – 30 Jan 2023 | Medical Devices & Rad Health | Clean | |
| 20 Aug 2021 – 7 Sep 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Jan 2019 – 15 Feb 2019 | Medical Devices & Rad Health | WL | View 483 → |
| 6 Aug 2014 – 7 Aug 2014 | Medical Devices & Rad Health | Clean | |
| 20 Jul 2012 | Not recorded | 483 | View 483 → |
| 22 Jul 2009 | Not recorded | 483 | On file |
| 5 Mar 2008 | Not recorded | 483 | On file |
| 7 Feb 2005 | Not recorded | Clean | |
| 11 Jul 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Debara R Reese3 insp.
Charles M Spyr2 insp.
Ian A Pilcher1 insp.
Cynthia A Harris1 insp.
Eric E Joneson1 insp.
Thomas A Peter1 insp.
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 | 5x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 806.20(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
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