FDA Inspection 1053525 — MIRAE MEDI&TECH CO., LTD.
The FDA completed an inspection of MIRAE MEDI&TECH CO., LTD. on Apr 26, 2018 in Cheonan. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 26, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cheonan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |