FDA Inspection
Unetixs Vascular, Inc.Unetixs Vascular, Inc. – FDA Inspection, Jun 3, 2011
Record Details
This FDA Inspection record concerns Unetixs Vascular, Inc., with an inspection on June 3, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Unetixs Vascular, Inc.
- Inspection Date
- June 3, 2011
- Product Type
- Devices
View Company Profile
ID · 3c3766a5-129c-4da9-b2fd-cfcdd243eb7a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 728239
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Unetixs Vascular, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2025 | OAI | New England District Office | Compliance: Medical Devices |
| September 16, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 30, 2021 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 29, 2019 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 11, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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