FDA Inspection 1115962 — HUREV Co., Ltd.
The FDA completed an inspection of HUREV Co., Ltd. on January 17, 2020 in Wonju. 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
- January 17, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wonju (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |