Company
JapanShionogi Pharma Co., Ltd., Isawa-Gun, Japan – FDA Inspections
Inspection records and compliance data for Shionogi Pharma Co., Ltd. in Isawa-Gun. 8 FDA inspections on record (1 OAI), 2 Form 483s, last inspected July 01, 2025.
Company Profile
This profile covers Shionogi Pharma Co., Ltd. based in Isawa-Gun, Japan.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 3
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected July 26, 2010. Last inspected July 1, 2025.
Most cited issue areas
- Cleaning System1 inspection
- Mfg / Processing Operations Area1 inspection
- Procedures for sterile drug products1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 1, 2025 | OAI | Human Drugs · Drug Quality Assurance | 1275087 |
| March 15, 2019 | Not classified | Human Drugs | 1085190 |
| September 28, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1069417 |
| September 16, 2016 | NAI | Human Drugs · Drug Quality Assurance | 1009607 |
| September 16, 2016 | VAI | Human Drugs · Drug Quality Assurance | 1009606 |
| April 1, 2014 | VAI | Human Drugs · Drug Quality Assurance | 874759 |
| February 2, 2012 | NAI | Human Drugs · Drug Quality Assurance | 772467 |
| July 26, 2010 | VAI | Human Drugs · Drug Quality Assurance | 676812 |
FDA documents
Form 483s (2)
People (4)
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Company Information
Name
Shionogi Pharma Co., Ltd.
FEI Number
3002808135
Address
Moriyama 7, Nishine; Kanegasaki-Cho, Isawa-Gun, Japan
Country
Japan
ID: bb3e5dcd-52f9-4971-9747-4c04b63ba0fa