Overview
- 1 public-safe observation is available for this inspection.
- 1 structured CFR citation is represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Apr 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Christopher R Czajka
Inspected site
CPChugai Pharma Manufacturing Co., LtdUtsunomiya, Japan
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
Source document
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Form 483 source document
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- 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