FDA Inspection 1320894 — Machida Endoscope Co., Ltd.
The FDA completed an inspection of Machida Endoscope Co., Ltd. on May 28, 2026 in Abiko. 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
- May 28, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Abiko (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 23125 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not complete prior to release of product |
| 23170 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes lack required elements |
| 23193 | ISO 13485:2016 Clause 7.6 | Procedures for monitoring and measuring equipment requirements not documented |