Shionogi Pharma Co., Ltd.
FDA inspection history in Kanegasaki, 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 Kanegasaki, Japan.
- 2025One Form 483, at Kanegasaki, Japan.
- 2025The longest 483 on file: 4 observations over 6 pages at Kanegasaki, Japan.
Cited most
Across all Shionogi Pharma Co. observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42(c)(10)(v)Design and construction features2
- 21 CFR 211.56Sanitation1
The complete Shionogi 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
Kanegasaki, Japan
Two Form 483s · 2019 to 2025 · 4 observations
Latest: Form 483, Jul 1, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-07-01 | 483 Form 483 | Kanegasaki, Japan | 4 | $99 |
| 2019-03-15 | 483 Form 483 | Kanegasaki, Japan | — | $99 |
Investigators on these documents
Anastasia M. Shields (1)Jessica S. Estriplet (1)Jiao Yang (1)
FEI number 3002808135 · most recent document Jul 1, 2025
About Shionogi Pharma Co., Ltd.
How many FDA Form 483s has Shionogi Pharma Co., Ltd. received?
FDA Intel has 2 Form 483s on file for Shionogi Pharma Co., Ltd.; the most recent is dated Jul 1, 2025.
When was Shionogi Pharma Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Shionogi Pharma Co., Ltd. is a Form 483 dated Jul 1, 2025, for the site in Kanegasaki, Japan.
What did FDA cite at Shionogi Pharma Co., Ltd.?
The regulations cited most in the observations on file for Shionogi Pharma Co., Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.42(c)(10)(v) (Design and construction features), 2 times; 21 CFR 211.56 (Sanitation), 1 time.