Company
JapanSumika Chemical Analysis Service, Ltd., Oita, Japan – FDA Inspections
Inspection records and compliance data for Sumika Chemical Analysis Service, Ltd. in Oita. 6 FDA inspections on record, 1 Form 483, last inspected November 07, 2025.
Company Profile
This profile covers Sumika Chemical Analysis Service, Ltd. based in Oita, Japan.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 30, 2010. Last inspected November 7, 2025.
Most cited issue areas
- Backup data not assured as exact and complete1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 7, 2025 | Not classified | Human Drugs | 1295706 |
| November 13, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1109519 |
| June 22, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1060052 |
| September 12, 2014 | VAI | Human Drugs · Drug Quality Assurance | 899691 |
| February 24, 2012 | NAI | Human Drugs · Drug Quality Assurance | 790523 |
| July 30, 2010 | VAI | Human Drugs · Drug Quality Assurance | 676820 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Sumika Chemical Analysis Service, Ltd.
FEI Number
3007378821
Address
2200, Oazatsurusaki, Oita, Japan
Country
Japan
ID: 075ab6c9-b05d-47d0-8d9a-0aa4807153a6