Terumo Corporation
FDA inspection history in SHOWACHO, Japan, 2023 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24Two Form 483s, at SHOWACHO, Japan.
- 2023The longest 483 on file: 8 observations over 10 pages at SHOWACHO, Japan.
Cited most
Across all Terumo observations on file
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.110(b)Sampling and testing of in-process materials and drug products1
The complete Terumo 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
SHOWACHO, Japan
Two Form 483s · 2023 to 2024 · 14 observations
Latest: Form 483, Dec 13, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-13 | 483 Form 483 | SHOWACHO, Japan | 6 | $99 |
| 2023-03-21 | 483 Form 483 | SHOWACHO, Japan | 8 | $99 |
Investigators on these documents
Marcellinus D. Dordunoo (1)Melanie W. Pishnery (1)Ruo H. Xu (1)Zhong Li (1)
FEI number 3003752255 · most recent document Dec 13, 2024
About Terumo Corporation
How many FDA Form 483s has Terumo Corporation received?
FDA Intel has 2 Form 483s on file for Terumo Corporation; the most recent is dated Dec 13, 2024.
When was Terumo Corporation last inspected by FDA?
The most recent FDA inspection document on file for Terumo Corporation is a Form 483 dated Dec 13, 2024, for the site in SHOWACHO, Japan.
What did FDA cite at Terumo Corporation?
The regulations cited most in the observations on file for Terumo Corporation are 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.