FDA Inspection 1214471 — SM ENG. Co. Ltd.
The FDA completed an inspection of SM ENG. Co. Ltd. on Jul 21, 2023 in Sasang. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 21, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sasang (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |