FDA Inspection 636113 — Angiodynamics, Inc.
The FDA completed an inspection of Angiodynamics, Inc. on December 16, 2009 in Queensbury, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 16, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Queensbury, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2598 | 21 CFR 820.30(d) | Design output procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3144 | 21 CFR 820.160(a) | Control/distribution procedures |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 4189 | 21 CFR 820.198(a) | General |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |