Overview
- 11 public-safe observations are available for this inspection.
- 10 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
17 Feb 2010
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Cody D Rickman, Shirley J Berryman, Megan M Kirk, Robin K Reel
17 Feb 2010
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Cody D Rickman, Shirley J Berryman, Megan M Kirk, Robin K Reel
17 Feb 2010
21 CFR 211.84(c)(2)
Containers sampled so as to prevent contamination
Cited by Cody D Rickman, Shirley J Berryman, Megan M Kirk, Robin K Reel
17 Feb 2010
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Cody D Rickman, Shirley J Berryman, Megan M Kirk, Robin K Reel
17 Feb 2010
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Cody D Rickman, Shirley J Berryman, Megan M Kirk, Robin K Reel
Inspected site
IAIvy Animal Health, Inc.Overland Park, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 11 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