Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2018-06-13.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Jun 2018 – 13 Jun 2018 | Medical Devices & Rad Health | Clean | |
| 3 Feb 2010 | Not recorded | 483 | View 483 → |
| 12 Dec 2007 | Not recorded | Clean | |
| 10 Feb 2006 | Not recorded | Clean | |
| 28 Feb 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Feb 2010
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Eric S Pittman
Investigators
FDA investigators tied to this site in the record.
Amy S Graf1 insp.
Eric S Pittman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Omnitech Systems, Inc.'s 1 Form 483
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