Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
21 Mar 2023
21 CFR 211.110(b)
In-process conformity - examination, sample testing
Cited by Melanie W Pishnery, Marcellinus D Dordunoo
21 Mar 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Melanie W Pishnery, Marcellinus D Dordunoo
21 Mar 2023
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Melanie W Pishnery, Marcellinus D Dordunoo
21 Mar 2023
21 CFR 211.28(b)
Habits of good sanitation & health
Cited by Melanie W Pishnery, Marcellinus D Dordunoo
21 Mar 2023
21 CFR 211.42(c)(10)
Aseptic Processing Area
Cited by Melanie W Pishnery, Marcellinus D Dordunoo
Inspected site
TCTerumo CorporationNakakoma-Gun, Japan
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | 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 8 observations
The source PDF, 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