Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Apr 2010
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Lisa L Gilliam, Marion D Wimberly
2 Apr 2010
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Lisa L Gilliam, Marion D Wimberly
2 Apr 2010
21 CFR 211.160(b)(2)
In-process materials - sampling, testing procedures
Cited by Lisa L Gilliam, Marion D Wimberly
2 Apr 2010
21 CFR 211.165(c)
Sampling and testing plans not described
Cited by Lisa L Gilliam, Marion D Wimberly
Inspected site
IIIodiTech, Inc.Kansas City, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | 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