FDA Inspection 1275014 — Gunze Limited
The FDA completed an inspection of Gunze Limited on Jun 12, 2025 in Ayabe. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 12, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ayabe (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3837 | 21 CFR 820.25(b) | Training records |