Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-08-19.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Aug 2022 – 19 Aug 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Apr 2017 – 2 May 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Jul 2014 – 24 Jul 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Feb 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
John A Sciacchitano2 insp.
Emir Galevi1 insp.
Preston M Lee1 insp.
Brian R Sweeney1 insp.
Abby E Pelletier1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1002.10 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 1002.13 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind OmniGuide, 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