FDA Inspection
Angiodynamics, Inc.Angiodynamics, Inc. – FDA Inspection, Jan 13, 2011
Record Details
This FDA Inspection record concerns Angiodynamics, Inc., with an inspection on January 13, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Angiodynamics, Inc.
- Inspection Date
- January 13, 2011
- Product Type
- Devices
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ID · ad6ec7e5-2e54-43f3-9333-a6ff14f6c34a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 705295
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Angiodynamics, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 10, 2025 | NAI | New York District Office | Postmarket Assurance: Medical Devices |
| April 21, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 4, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 24, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 10, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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