Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2011-03-28.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Mar 2011 | Not recorded | Clean | |
| 11 Mar 2011 | Not recorded | 483 | View 483 → |
| 17 Sep 2010 | Not recorded | 483 | View 483 → |
| 10 Jul 2009 | Not recorded | WL | View 483 → |
| 2 May 2006 | Not recorded | Clean | |
| 28 Jul 2005 | Not recorded | Clean | |
| 23 Jul 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Mar 2011
21 CFR 110.20(b)(4)
Floors, walls and ceilings
Cited by Carla R Hinz, Jessica M Christman, Christopher M Sheehan
11 Mar 2011
21 CFR 110.37(e)(4)
Devices and fixtures
Cited by Carla R Hinz, Jessica M Christman, Christopher M Sheehan
11 Mar 2011
21 CFR 110.37(e)(5)
Signs
Cited by Carla R Hinz, Jessica M Christman, Christopher M Sheehan
11 Mar 2011
21 CFR 123.7(d)
Corrective action documentation
Cited by Carla R Hinz, Jessica M Christman, Christopher M Sheehan
11 Mar 2011
21 CFR 123.8(a)(3)
Verification - record review - frequency
Cited by Carla R Hinz, Jessica M Christman, Christopher M Sheehan
Investigators
FDA investigators tied to this site in the record.
Jennifer R Mathern2 insp.
Caroline H Le1 insp.
Carla R Hinz1 insp.
Jessica M Christman1 insp.
Christopher M Sheehan1 insp.
Isabel Y Espinosa1 insp.
Brent W Higgs1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.6(c)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.6(c)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.11(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.7(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Okami, Incorporated's 3 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