Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho
FDA inspection history in Suzuka, Japan, 2019 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Suzuka, Japan.
- 2025One Form 483, at Suzuka, Japan.
- 2025The longest 483 on file: 3 observations over 2 pages at Suzuka, Japan.
Cited most
Across all Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho observations on file
- 21 CFR 211.113(a)Control of microbiological contamination1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment1
- 21 CFR 211.84(b)Testing and approval or rejection of components, drug product containers, and closures1
The complete Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho 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
Suzuka, Japan
Two Form 483s · 2019 to 2025 · 4 observations
Latest: Form 483, Aug 7, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-08-07 | 483 Form 483 | Suzuka, Japan | 3 | $99 |
| 2019-11-22 | 483 Form 483 | Suzuka, Japan | 1 | $99 |
Investigators on these documents
FEI number 3003028650 · most recent document Aug 7, 2025
About Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho
How many FDA Form 483s has Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho received?
FDA Intel has 2 Form 483s on file for Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho; the most recent is dated Aug 7, 2025.
When was Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho last inspected by FDA?
The most recent FDA inspection document on file for Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho is a Form 483 dated Aug 7, 2025, for the site in Suzuka, Japan.
What did FDA cite at Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho?
The regulations cited most in the observations on file for Sumitomo Pharma Co., Ltd. 1450, Yasuzuka-Cho are 21 CFR 211.113(a) (Control of microbiological contamination), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time; 21 CFR 211.68(b) (Automatic, mechanical, and electronic equipment), 1 time.