Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-03-22.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Mar 2018 – 22 Mar 2018 | Medical Devices & Rad Health | Clean | |
| 10 Dec 2014 – 12 Dec 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Apr 2012 | Not recorded | 483 | View 483 → |
| 24 Jun 2010 | Not recorded | 483 | View 483 → |
| 11 Jun 2008 | Not recorded | 483 | On file |
| 29 Sep 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Apr 2012
21 CFR 820.30(g)
Design validation - Risk analysis
Cited by Graham N Giesen, Ashleigh P Barkans
18 Apr 2012
21 CFR 820.181
DMR - not or inadequately maintained
Cited by Graham N Giesen, Ashleigh P Barkans
Investigators
FDA investigators tied to this site in the record.
Graham N Giesen2 insp.
Stephen R Souza1 insp.
James D Hildreth1 insp.
Ashleigh P Barkans1 insp.
Scott A Nabe1 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 | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pedigo Products, Inc.'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