FDA Inspection
Microstim Technology, Inc.Microstim Technology, Inc. – FDA Inspection, Nov 18, 2016
Record Details
This FDA Inspection record concerns Microstim Technology, Inc., with an inspection on November 18, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fc962165-4523-4803-919e-725a3d52f4d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 997044
- 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
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Microstim Technology, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 3, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Microstim Technology, Inc.
- FDA Inspection 791510 - 2012-07-16
- FDA Inspection 559883 - 2009-02-03
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