FDA Inspection 1194084 — Nuga Medical Co., Ltd.
The FDA completed an inspection of Nuga Medical Co., Ltd. on Dec 8, 2022 in Wonju. 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
- Dec 8, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wonju (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |