FDA Inspection 705295 — Angiodynamics, Inc.
The FDA completed an inspection of Angiodynamics, Inc. on January 13, 2011 in Queensbury, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 13, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Queensbury, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |