Overview
- 8 public-safe observations are available for this inspection.
- 4 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.
27 Jan 2017
21 CFR 117.20(b)
Plant Construction and Design
Cited by Tiffany Chao, Andrew E Kay, Andrew T Todd
27 Jan 2017
21 CFR 117.20(b)
Plant Construction and Design
Cited by Tiffany Chao, Andrew E Kay, Andrew T Todd
27 Jan 2017
21 CFR 117.4
Training of employees and records
Cited by Tiffany Chao, Andrew E Kay, Andrew T Todd
27 Jan 2017
21 CFR 117.4
Training of employees and records
Cited by Tiffany Chao, Andrew E Kay, Andrew T Todd
27 Jan 2017
21 CFR 117.40
Equipment and Utensils - Design and Maintenance
Cited by Tiffany Chao, Andrew E Kay, Andrew T Todd
Inspected site
CACalbee America, Inc.Fairfield, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.20(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.4 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.80(a)(2) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 8 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