Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-03-07.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Mar 2017 – 7 Mar 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Sep 2014 – 24 Sep 2014 | Medical Devices & Rad Health | 483 | On file |
| 6 May 2013 – 24 May 2013 | Medical Devices & Rad Health | WL | View 483 → |
| 24 Jan 2013 | Not recorded | 483 | View 483 → |
| 11 Mar 2010 | Not recorded | Clean | |
| 17 Aug 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 May 2013
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Maribeth G Niesen
24 May 2013
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Maribeth G Niesen
24 May 2013
21 CFR 820.80(d)
Lack of or inadequate final acceptance procedures
Cited by Maribeth G Niesen
Investigators
FDA investigators tied to this site in the record.
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 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.200(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 4 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