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.
2 Aug 2012
21 CFR 211.67(b)
Written procedures fail to include
Cited by Ileana Barreto-Pettit, Juanita P Versace
2 Aug 2012
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Ileana Barreto-Pettit, Juanita P Versace
2 Aug 2012
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Ileana Barreto-Pettit, Juanita P Versace
2 Aug 2012
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Ileana Barreto-Pettit, Juanita P Versace
2 Aug 2012
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Ileana Barreto-Pettit, Juanita P Versace
Inspected site
TPTakeda Pharmaceutical Company LimitedYodogawa-Ku, Japan
Inspection team
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 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(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