Company
JapanSumitomo Dainippon Pharma Co., Ltd., Oita, Japan – FDA Inspections
Inspection records and compliance data for Sumitomo Dainippon Pharma Co., Ltd. in Oita. 6 FDA inspections on record, 3 Form 483s, last inspected July 11, 2025.
Company Profile
This profile covers Sumitomo Dainippon Pharma Co., Ltd. based in Oita, Japan.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 6
- NAI
- 0
- Form 483s
- 3
- Warning letters
- 0
First inspected July 30, 2010. Last inspected July 11, 2025.
Most cited issue areas
- Cleaning System1 inspection
- Computer control of master formula records1 inspection
- Establish, maintain and follow manufacturing SOPs1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 11, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1276963 |
| April 16, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1088923 |
| February 17, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1003840 |
| September 12, 2014 | VAI | Human Drugs · Drug Quality Assurance | 895955 |
| February 24, 2012 | VAI | Human Drugs · Drug Quality Assurance | 797370 |
| July 30, 2010 | VAI | Human Drugs · Drug Quality Assurance | 676813 |
FDA documents
Form 483s (2)
Other regulators (1)
People (4)
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Company Information
Name
Sumitomo Dainippon Pharma Co., Ltd.
FEI Number
3005619533
Address
2200, Oazatsurusaki, Oita, Japan
Country
Japan
ID: a14dd605-ff5f-4e7a-a71b-73f6eb72a9c6