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.
9 Aug 2019
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Gam S Zamil, Patric C Klotzbuecher
9 Aug 2019
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Gam S Zamil, Patric C Klotzbuecher
9 Aug 2019
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Gam S Zamil, Patric C Klotzbuecher
9 Aug 2019
21 CFR 211.194(a)
Complete test data included in records
Cited by Gam S Zamil, Patric C Klotzbuecher
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 211.100(b) | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 4 observations
The source PDF and 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