US Vascular, Inc. – FDA Inspection, Apr 24, 2017

Record Details

This FDA Inspection record concerns US Vascular, Inc., with an inspection on April 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: US Vascular, Inc.
Inspection Date: April 24, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: James D. Hildreth (FDA Associated Person)

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ID · d39b8691-08f3-42ed-bfd9-36337541128c

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 1010050
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.72(b)Calibration procedures - content
21 CFR 820.40Procedures not adequately established or maintained
21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint 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 US Vascular, Inc.

Date	Classification	Office	Project area
March 6, 2024	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
February 13, 2020	VAI	Center for Devices and Radiological Health	Compliance: Devices
March 21, 2019	VAI	Center for Devices and Radiological Health	Compliance: Devices
March 30, 2018	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
March 28, 2016	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices