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Form 483

Scientia Vascular, Inc. Form 483, 2025-11-11

FDA issued a Form 483 to Scientia Vascular, Inc. on 2025-11-11 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Scientia Vascular, Inc. · West Valley City, United States · Issued November 11, 2025

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

11 Nov 2025
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Monica L Gutierrez

Inspected site

SVScientia Vascular, Inc.West Valley City, United States

Inspection team

MLMonica L Gutierrez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere