Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
OIOkami, IncorporatedDenver, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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(b) | 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 483 report
Get the verbatim text of all 6 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere