Terumo Yamaguchi Corporation
FDA inspection history across 2 sites, 2020 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at SAYAMA, Japan.
- 2020The longest 483 on file: 10 observations over 4 pages at SAYAMA, Japan.
- 2023One Form 483, at Yamaguchi, Japan.
Cited most
Across all Terumo Yamaguchi observations on file
- 21 CFR 211.25Personnel qualifications3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.192Production record review1
The complete Terumo Yamaguchi file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Yamaguchi, Japan
One Form 483 · 2023 · 2 observations
Latest: Form 483, Mar 30, 2023 →SAYAMA, Japan
One Form 483 · 2020 · 10 observations
Latest: Form 483, Feb 19, 2020 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-30 | 483 Form 483 | Yamaguchi, Japan | 2 | $99 |
| 2020-02-19 | 483 Form 483 | SAYAMA, Japan | 10 | $99 |
Investigators on these documents
Marcellinus D. Dordunoo (1)Melanie W. Pishnery (1)Virginia A. Carroll (1)Wayne Seifert (1)
FEI number 3013611763 · most recent document Mar 30, 2023
About Terumo Yamaguchi Corporation
How many FDA Form 483s has Terumo Yamaguchi Corporation received?
FDA Intel has 2 Form 483s on file for Terumo Yamaguchi Corporation; the most recent is dated Mar 30, 2023.
When was Terumo Yamaguchi Corporation last inspected by FDA?
The most recent FDA inspection document on file for Terumo Yamaguchi Corporation is a Form 483 dated Mar 30, 2023, for the site in Yamaguchi, Japan.
What did FDA cite at Terumo Yamaguchi Corporation?
The regulations cited most in the observations on file for Terumo Yamaguchi Corporation are 21 CFR 211.25 (Personnel qualifications), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times.