FDA Inspection
Avantec Vascular CorporationAvantec Vascular Corporation – FDA Inspection, Jan 26, 2023
Record Details
This FDA Inspection record concerns Avantec Vascular Corporation, with an inspection on January 26, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a3582fcd-c74b-44af-9e3d-d2e30102e160
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195638
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Avantec Vascular Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2026 | NAI | Postmarket Assurance: Devices | |
| January 10, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 14, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 17, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Avantec Vascular Corporation
- FDA Inspection 1310026 - 2026-03-24
- FDA Inspection 1114776 - 2020-01-10
- FDA Inspection 833402 - 2013-05-14
- FDA Inspection 667195 - 2010-06-17
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