FDA Inspection
Neurotron Medical Inc.Neurotron Medical Inc. – FDA Inspection, Nov 23, 2015
Record Details
This FDA Inspection record concerns Neurotron Medical Inc., with an inspection on November 23, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Neurotron Medical Inc.
- Inspection Date
- November 23, 2015
- Product Type
- Devices
View Company Profile
ID · 3a3af0da-d3fb-4dbb-9e3c-03b5a7df10c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 971930
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Neurotron Medical Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 23, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Neurotron Medical Inc.
- FDA Inspection 778084 - 2012-04-27
- FDA Inspection 563969 - 2009-02-23
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