FDA Inspection
Neurometrix, Inc.Neurometrix, Inc. – FDA Inspection, May 27, 2026
Record Details
This FDA Inspection record concerns Neurometrix, Inc., with an inspection on May 27, 2026, issued by the New Jersey District Office, covering medical devices & rad health.
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ID · e461872b-3b6c-430b-875d-c17eb1d63662
Inspection Facts
- Inspection number
- 1319250
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.3.6Design and development verification not performed
- ISO 13485:2016 Clause 8.2.2Lack of documented justification for not investigating complaint(s)
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Other FDA inspections of Neurometrix, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 7, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 7, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 20, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 23, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Neurometrix, Inc.
- FDA Inspection 1032529 - 2017-11-15
- FDA Inspection 929229 - 2015-05-07
- FDA Inspection 929228 - 2015-05-07
- FDA Inspection 773749 - 2012-03-20
- FDA Inspection 578341 - 2009-04-23
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