1063811
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 30, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Gunsan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 642 | 21 CFR 803.18(b)(1)(i) | Adverse events--all info not in file |