FDA Inspection 1282002 — BCM Co., Ltd.
The FDA completed an inspection of BCM Co., Ltd. on September 18, 2025 in Goyang. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 18, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Goyang (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |