Overview
- 7 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.
1 May 2013
21 CFR 212.30(a)
Prevention of contamination
Cited by Linda Thai, Ademola O Daramola, Matthew J Johnson
1 May 2013
21 CFR 212.50
Adequate controls (general)
Cited by Linda Thai, Ademola O Daramola, Matthew J Johnson
1 May 2013
21 CFR 212.60(a)
Testing procedures
Cited by Linda Thai, Ademola O Daramola, Matthew J Johnson
1 May 2013
21 CFR 212.60(b)
Lab sampling and test procedures
Cited by Linda Thai, Ademola O Daramola, Matthew J Johnson
1 May 2013
21 CFR 212.60(b)
Testing Procedures- Conformance to Standards
Cited by Linda Thai, Ademola O Daramola, Matthew J Johnson
Inspected site
CHCardinal Health 414 LLCPhoenix, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.60(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.71(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