FDA Inspection 1274830 — Infus Medical Co., Ltd.
The FDA completed an inspection of Infus Medical Co., Ltd. on June 12, 2025 in Amphoe Muang Khon Kaen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 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 |