Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
19 Apr 2011
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Kellia N Hicks, Robert S Woodruff
19 Apr 2011
21 CFR 211.180(e)(2)
Items to cover on annual reviews
Cited by Kellia N Hicks, Robert S Woodruff
19 Apr 2011
21 CFR 211.192
Written record of investigation incomplete
Cited by Kellia N Hicks, Robert S Woodruff
19 Apr 2011
21 CFR 211.198(b)(2)
Complaint Investigation/Follow-Up Findings
Cited by Kellia N Hicks, Robert S Woodruff
Inspected site
CSCentral Solutions, Inc.Kansas City, United States
Inspection team
RSRobert S Woodruff
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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