Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-04-20.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Apr 2017 – 20 Apr 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 May 2014 – 3 Jun 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Jul 2012 | Not recorded | 483 | View 483 → |
| 21 Jul 2009 | Not recorded | 483 | View 483 → |
| 16 Aug 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Apr 2017
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Cynthia L Gorveatt
20 Apr 2017
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Cynthia L Gorveatt
20 Apr 2017
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Cynthia L Gorveatt
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 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Frye Electronics, 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