Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-03-05.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Feb 2019 – 5 Mar 2019 | Medical Devices & Rad Health | Clean | |
| 27 Oct 2014 – 31 Oct 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Dec 2013 – 12 Dec 2013 | Medical Devices & Rad Health | WL | View 483 → |
| 10 Aug 2011 | Not recorded | 483 | View 483 → |
| 30 Sep 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Dec 2013
21 CFR 820.70(g)(1)
Maintenance schedule, Lack of or inadequate schedule
Cited by Trang N Cox
12 Dec 2013
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Trang N Cox
Investigators
FDA investigators tied to this site in the record.
Trang N Cox2 insp.
Sayeeda Hdabe1 insp.
Myoshi M Francis1 insp.
Amanda L Evanco1 insp.
Patricia F Hudson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.40(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Owen Mumford USA, Inc.'s 4 Form 483s
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