Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-09-10.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Sep 2020 – 10 Sep 2020 | Medical Devices & Rad Health | 483 | On file |
| 11 Aug 2017 – 16 Aug 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Apr 2013 – 30 Apr 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Jul 2008 | Not recorded | Clean | |
| 13 Sep 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Aug 2017
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Stephen R Souza
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 | 3x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cadwell Industries, Inc.'s 3 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