Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-09-28.
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 |
|---|---|---|---|
| 15 Sep 2017 – 28 Sep 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Oct 2014 – 6 Nov 2014 | Medical Devices & Rad Health | Clean | |
| 24 Oct 2012 | Not recorded | 483 | View 483 → |
| 26 Jun 2009 | Not recorded | 483 | View 483 → |
| 20 May 2008 | Not recorded | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Sep 2017
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Benjamin J Dastoli
28 Sep 2017
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Benjamin J Dastoli
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 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Volk Optical 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