Sumitomo Pharma Co., Ltd.
FDA inspection history in Oita, Japan, 2019 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2025: one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Oita, Japan.
- 2025One amended 483, at Oita, Japan.
- 2025The longest 483 on file: 4 observations over 5 pages at Oita, Japan.
Cited most
Across all Sumitomo Pharma Co. observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.160General requirements1
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment1
The complete Sumitomo Pharma Co. 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
Oita, Japan
One amended 483 and one Form 483 · 2019 to 2025 · 7 observations
Latest: Form 483, Jul 11, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-07-11 | Amended 483 Amended 483 | Oita, Japan | 4 | $99 |
| 2019-04-16 | 483 Form 483 | Oita, Japan | 3 | $99 |
Investigators on these documents
Anastasia M. Shields (1)Jessica S. Estriplet (1)Linda F. Murphy (1)Zhongren Wu (1)
FEI number 3005619533 · most recent document Jul 11, 2025
About Sumitomo Pharma Co., Ltd.
How many FDA Form 483s has Sumitomo Pharma Co., Ltd. received?
FDA Intel has 2 Form 483s on file for Sumitomo Pharma Co., Ltd.; the most recent is dated Jul 11, 2025.
When was Sumitomo Pharma Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Sumitomo Pharma Co., Ltd. is a Form 483 dated Jul 11, 2025, for the site in Oita, Japan.
What did FDA cite at Sumitomo Pharma Co., Ltd.?
The regulations cited most in the observations on file for Sumitomo Pharma Co., Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.160 (General requirements), 1 time.