FDA Inspection
Gunze LimitedGunze Limited – FDA Inspection, Jun 12, 2025
Record Details
This FDA Inspection record concerns Gunze Limited, with an inspection on June 12, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 7a222722-8e34-4106-a80e-fc29dd13a3d6
Inspection Facts
- Inspection number
- 1275014
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.25(b)Training records
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of Gunze Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Gunze Limited
- FDA Inspection 1091206 - 2018-12-13
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