FDA Inspection 825909 — ALPINION MEDICAL SYSTEMS CO. LTD
The FDA completed an inspection of ALPINION MEDICAL SYSTEMS CO. LTD on March 15, 2013 in Dongan, Anyang. 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 15, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dongan, Anyang (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 4189 | 21 CFR 820.198(a) | General |