FDA Inspection
Scientia Vascular, Inc.Scientia Vascular, Inc. – FDA Inspection, Nov 11, 2025
Record Details
This FDA Inspection record concerns Scientia Vascular, Inc., with an inspection on November 11, 2025, issued by the Denver District Office, covering medical devices & rad health.
- Company
- Scientia Vascular, Inc.
- Inspection Date
- November 11, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 7c00813c-6739-46e1-b084-ea47246ad4e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1290968
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Scientia Vascular, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 5, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Scientia Vascular, Inc.
- FDA Inspection 1001303 - 2017-01-11
- FDA Inspection 858140 - 2013-12-05
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