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•United States

Neurometrix, Inc., Rockaway, NJ – FDA Inspections

Inspection records and compliance data for Neurometrix, Inc. in Rockaway, NJ. 6 FDA inspections on record, 1 Form 483, last inspected May 27, 2026.

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Company Profile

This profile covers Neurometrix, Inc. based in Rockaway, NJ, United States.

FDA Inspection History

FDA inspections
6
OAI
0
VAI
4
NAI
1
Unclassified
1
Form 483s
1
Warning letters
0

First inspected April 23, 2009. Last inspected May 27, 2026.

Most cited issue areas

  • Lack of Written MDR Procedures2 inspections
  • Design and development verification not performed1 inspection
  • DHR content1 inspection

FDA inspections (6)

DateResultFDA center(s)Insp. #
May 27, 2026Not classifiedMedical Devices & Rad Health · Compliance: Devices1319250
November 15, 2017NAIMedical Devices & Rad Health · Compliance: Devices1032529
May 7, 2015VAIMedical Devices & Rad Health · Compliance: Devices929229
May 7, 2015VAIMedical Devices & Rad Health · Compliance: Devices929228
March 20, 2012VAIMedical Devices & Rad Health · Compliance: Devices773749
April 23, 2009VAIMedical Devices & Rad Health · Postmarket Assurance: Devices578341
FDA documents

Form 483s (1)

  • Form 483s · May 27, 2026
People (1)
Monica L. Gutierrez
Person
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Company Information

Name

Neurometrix, Inc.

FEI Number

3011412151

Address

200 Forge Way Ste 205, Rockaway, NJ 07866-2055, United States

Country

United States

ID: 415c4be9-8f3f-4225-855b-3c72aa169773

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