FDA Inspection 1200437 — IMANI
The FDA completed an inspection of IMANI on March 22, 2023 in Yongin-Si. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 22, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Yongin-Si (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 3239 | 21 CFR 820.72(b) | Remedial action - documentation |