Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-11-16.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Nov 2017 – 16 Nov 2017 | Medical Devices & Rad Health | 483 | On file |
| 11 Jul 2016 – 14 Jul 2016 | Medical Devices & Rad Health | Clean | |
| 14 Dec 2012 | Not recorded | Clean | |
| 15 Jul 2011 | Not recorded | 483 | On file |
| 10 Dec 2010 | Not recorded | 483 | View 483 → |
| 26 Apr 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Dec 2010
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Eric M Padgett, Steven D Kehoe
Investigators
FDA investigators tied to this site in the record.
Eric M Padgett3 insp.
Edward E Lockwood1 insp.
Robert J Ham1 insp.
Sherry G Bous1 insp.
Steven D Kehoe1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Synergetics 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