FDA Inspection 1274830 — Infus Medical Co., Ltd.
The FDA completed an inspection of Infus Medical Co., Ltd. on Jun 12, 2025 in Amphoe Muang Khon Kaen. 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). 2 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
- Compliance: Devices
- Location
- Amphoe Muang Khon Kaen (Thailand)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |