FDA Inspection 1224275 — Machida Endoscope Co., Ltd.
The FDA completed an inspection of Machida Endoscope Co., Ltd. on Dec 7, 2023 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 7, 2023
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Abiko (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |