FDA Inspection
Neurotron. Inc.Neurotron. Inc. – FDA Inspection, Apr 10, 2017
Record Details
This FDA Inspection record concerns Neurotron. Inc., with an inspection on April 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d5eb77a3-b73a-45c2-8cb9-19f2eb582e13
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007463
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Neurotron. Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| December 17, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Neurotron. Inc.
- FDA Inspection 1007462 - 2017-04-10
- FDA Inspection 799351 - 2012-09-18
- FDA Inspection 798374 - 2012-09-12
- FDA Inspection 682551 - 2010-09-27
- FDA Inspection 554398 - 2008-12-17
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