Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-07-19.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Jul 2016 – 19 Jul 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jul 2014 – 25 Jul 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 May 2014 – 16 May 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Feb 2010 | Not recorded | WL | |
| 31 Jul 2009 | Not recorded | Clean | |
| 7 Oct 2008 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 May 2014
21 CFR 820.65
Traceability Lack of or inadequate {see also 820.120(e)}
Cited by Kelvin Cheung
Investigators
FDA investigators tied to this site in the record.
Jocelyn E Massey1 insp.
Ka L Wong1 insp.
Kelvin Cheung1 insp.
Jeff M Uriarte1 insp.
Mei-Chen Mu1 insp.
Cntrctmntr Anderson1 insp.
Scott K Zika1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(e) | 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 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind VertiFlex, 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