FDA Inspection 931215 — AngioSystems Inc
The FDA completed an inspection of AngioSystems Inc on June 18, 2015 in Ducktown, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 18, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ducktown, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |