Shionogi Pharma Co., Ltd.
FDA inspection history in Tokushima, Japan, 2016 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Tokushima, Japan.
- 2016The longest 483 on file: 12 observations over 7 pages at Tokushima, Japan.
- 2023One Form 483, at Tokushima, Japan.
Cited most
Across all Shionogi Pharma Co. observations on file
- 21 CFR 211.160General requirements4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.188Batch production and control records2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
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
Tokushima, Japan
Two Form 483s · 2016 to 2023 · 16 observations
Latest: Form 483, Oct 20, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-20 | 483 Form 483 | Tokushima, Japan | 4 | $99 |
| 2016-08-05 | 483 Form 483 | Tokushima, Japan | 12 | $99 |
Investigators on these documents
FEI number 3008353674 · most recent document Oct 20, 2023
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 Oct 20, 2023.
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 Oct 20, 2023, for the site in Tokushima, 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 211.160 (General requirements), 4 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times; 21 CFR 211.188 (Batch production and control records), 2 times.