Company
JapanSekisui Medical Co., Ltd, Ryugasaki, Japan – FDA Inspections
Inspection records and compliance data for Sekisui Medical Co., Ltd in Ryugasaki. 3 FDA inspections on record, 1 Form 483, 1 warning letter, last inspected June 11, 2026.
Company Profile
This profile covers Sekisui Medical Co., Ltd based in Ryugasaki, Japan.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected October 17, 2019. Last inspected June 11, 2026.
Most cited issue areas
- Procedures for purchasing process not documented1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 11, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1324302 |
| April 18, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1238155 |
| October 17, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1109094 |
FDA documents
Warning Letters (1)
EIRs (1)
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Company Information
Name
Sekisui Medical Co., Ltd
FEI Number
3006769061
Address
3 Chome 3-1 301-852, Koyodai, Ryugasaki, Japan
Country
Japan
ID: de99524b-4a51-4939-a942-80fa9fecfa67