FDA Inspection
Motion Analysis CorporationMotion Analysis Corporation – FDA Inspection, Nov 7, 2016
Record Details
This FDA Inspection record concerns Motion Analysis Corporation, with an inspection on November 7, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fd309947-24c3-4204-bc2e-9da957464f0a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003151
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Motion Analysis Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 2, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 24, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Motion Analysis Corporation
- FDA Inspection 1018699 - 2017-07-21
- FDA Inspection 834109 - 2013-06-02
- FDA Inspection 741250 - 2011-08-24
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