FDA Inspection 621402 — AirSep Corp.
The FDA completed an inspection of AirSep Corp. on October 5, 2009 in Ball Ground, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 5, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ball Ground, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 4189 | 21 CFR 820.198(a) | General |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |