Company
JapanGunze Limited, Ayabe, Japan – FDA Inspections
Inspection records and compliance data for Gunze Limited in Ayabe. 2 FDA inspections on record, 1 Form 483, last inspected June 12, 2025.
Company Profile
This profile covers Gunze Limited based in Ayabe, Japan.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected December 13, 2018. Last inspected June 12, 2025.
Most cited issue areas
- Nonconforming product control1 inspection
- Quality audits - auditor independence1 inspection
- Training records1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 12, 2025 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1275014 |
| December 13, 2018 | Not classified | Medical Devices & Rad Health | 1091206 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Gunze Limited
FEI Number
3010668881
Address
Natsumegaichi 46, Aono, Ayabe, Japan
Country
Japan
ID: d4d956f2-d86d-4223-b47c-db8cd3b0059b