Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
1 Oct 2010
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Kellia N Hicks, Tara L Breckenridge
1 Oct 2010
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Kellia N Hicks, Tara L Breckenridge
1 Oct 2010
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Kellia N Hicks, Tara L Breckenridge
1 Oct 2010
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Kellia N Hicks, Tara L Breckenridge
1 Oct 2010
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Kellia N Hicks, Tara L Breckenridge
Inspected site
CICentaur, Inc.Olathe, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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