Nevro Corporation – FDA Inspection, Nov 3, 2017

Record Details

This FDA Inspection record concerns Nevro Corporation, with an inspection on November 3, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: Nevro Corporation
Inspection Date: November 3, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Adam S. Freeman (FDA Associated Person)

View Company Profile

ID · b553accd-8391-4b02-b454-100ea8d935a0

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1030660
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Nevro Corporation

Date	Classification	Office	Project area
August 13, 2025	OAI	San Francisco District Office	Postmarket Assurance: Medical Devices
December 20, 2023	VAI	Center for Devices and Radiological Health	Compliance: Devices
April 26, 2022	NAI	Center for Devices and Radiological Health	Bioresearch Monitoring
March 21, 2019	NAI	Center for Devices and Radiological Health	Bioresearch Monitoring
March 16, 2018	NAI	Center for Devices and Radiological Health	Compliance: Devices