FDA Inspection 975119 — IMEDICOM CO., LTD
The FDA completed an inspection of IMEDICOM CO., LTD on Jun 2, 2016 in Gunpo-si. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 2, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Gunpo-si (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 3109 | 21 CFR 820.70(d) | Personnel requirements, Lack of or inadequate requirements |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |