Unetixs Vascular, Inc. – FDA Inspection, Mar 29, 2017

Record Details

This FDA Inspection record concerns Unetixs Vascular, Inc., with an inspection on March 29, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: Unetixs Vascular, Inc.
Inspection Date: March 29, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Maryam Tabatabaie (Company Rep)

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ID · 316171f2-ed85-4bf0-a0a2-68766ceeab0f

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1006990
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.72(a)Equipment suitability & capability
21 CFR 820.30(g)Design validation - user needs and intended uses
21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.60Identification procedures, Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures

Showing 10 of 14 citations.

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Other FDA inspections of Unetixs Vascular, Inc.

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