Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-08-29.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Aug 2018 – 29 Aug 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Jul 2016 – 12 Aug 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Jul 2014 – 2 Sep 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 May 2010 | Not recorded | 483 | View 483 → |
| 6 Jan 2006 | Not recorded | Clean | |
| 1 Jul 2004 | Not recorded | Clean | |
| 17 Jun 2003 | Not recorded | Clean | |
| 18 Dec 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Aug 2018
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Laureen M Geniusz
29 Aug 2018
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Laureen M Geniusz
29 Aug 2018
21 CFR 820.75(c)
Documentation - review in response to changes or deviations
Cited by Laureen M Geniusz
Investigators
FDA investigators tied to this site in the record.
Laureen M Geniusz3 insp.
Mary E Storch1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Western / Scott Fetzer Company'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