NeuroMetrix, Inc.

FDA establishment 3011412151, Rockaway, New Jersey, United States. Part of Neurometrix, Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.

Inspections: 6
Official action indicated: 0
Last inspection ended: May 27, 2026
Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

How to read this

A hatched bar is a year that is not over, so its count covers only part of the year.

02019

02021

02023

02025

02027

Most Cited at This Site

Inspections citing each reference

21 CFR 803.17: Lack of Written MDR Procedures2
ISO 13485:2016 Clause 7.3.6: Design and development verification not performed1
ISO 13485:2016 Clause 7.1: Records of risk management activities in product realization not maintained1
ISO 13485:2016 Clause 8.2.2: Lack of documented justification for not investigating complaint(s)1
21 CFR 820.184(e): ID label, labeling1
21 CFR 820.25(b): Training records1
21 CFR 820.30(h): Incorrect translation to production specifications1
21 CFR 820.100(a): Lack of or inadequate procedures1

Inspections

6 inspections, newest first


May 27, 2026	Devices · Compliance: Devices	4 cited references ISO 13485:2016 Clause 7.3.6. Design and development verification not performed Design and development verification was not adequately performed in accordance with planned and documented arrangements to ensure that design and development outputs met design and development input requirements. 21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been implemented. ISO 13485:2016 Clause 7.1. Records of risk management activities in product realization not maintained Records of risk management activities in product realization were not maintained. ISO 13485:2016 Clause 8.2.2. Lack of documented justification for not investigating complaint(s) Justification for not investigating a complaint(s) was not documented.	Voluntary Action Indicated (VAI)
Nov 15, 2017	Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices	None posted	No Action Indicated (NAI)
May 7, 2015	Devices · Compliance: Devices	1 cited reference 21 CFR 820.184(e). ID label, labeling The device history record does not include the primary identification label and labeling for each device.	Voluntary Action Indicated (VAI)
May 7, 2015	Devices · Compliance: Devices	2 cited references 21 CFR 820.25(b). Training records Personnel training is not documented. 21 CFR 820.30(h). Incorrect translation to production specifications The device design was not correctly translated into production specifications.	Voluntary Action Indicated (VAI)
Mar 20, 2012	Devices · Compliance: Devices	2 cited references 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established. 21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with 21 CFR 820.	Voluntary Action Indicated (VAI)
Apr 23, 2009	Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices	2 cited references 21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed. 21 CFR 820.198(e). Maintained Records of complaint investigations are not maintained by the formally designated unit.	Voluntary Action Indicated (VAI)

Identifiers

FEI number: 3011412151
FDA firm profile: Data Dashboard
Inspection program: 7382.850, Inspection of Medical Device Manufacturers
Company: Neurometrix, Inc.

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard, warning letters and enforcement reports