FDA Inspection
Neurotron. Inc.Neurotron. Inc. – FDA Inspection, Aug 21, 2026
Record Details
This FDA Inspection record concerns Neurotron. Inc., with an inspection on August 21, 2026, issued by the Denver District Office, covering medical devices & rad health.
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ID · f62206e1-6c2e-4186-bfd3-aff25d2435d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1332018
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities not established or implemented
- ISO 13485:2016 Clause 7.5.4Servicing procedures and reference materials and measurements not documented
- ISO 13485:2016 Clause 7.5.8Product status identification was not maintained
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Neurotron. Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 10, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 10, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 18, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 12, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 27, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Neurotron. Inc.
- FDA Inspection 1007463 - 2017-04-10
- FDA Inspection 1007462 - 2017-04-10
- FDA Inspection 799351 - 2012-09-18
- FDA Inspection 798374 - 2012-09-12
- FDA Inspection 682551 - 2010-09-27
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