Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
6 Nov 2015
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Angela E Glenn, Santos E Camara
6 Nov 2015
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Angela E Glenn, Santos E Camara
6 Nov 2015
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Angela E Glenn, Santos E Camara
6 Nov 2015
21 CFR 211.194(a)
Complete test data included in records
Cited by Angela E Glenn, Santos E Camara
6 Nov 2015
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Angela E Glenn, Santos E Camara
Inspected site
CPChugai Pharma Manufacturing Co., LtdKita, Japan
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 observations
The full inspection record, as Atlas holds it, 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