FDA Inspection
Motion Analysis CorporationMotion Analysis Corporation – FDA Inspection, Jul 21, 2017
Record Details
This FDA Inspection record concerns Motion Analysis Corporation, with an inspection on July 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Adam S. Freeman (FDA Associated Person)
- Seema S. Singh (Issuing Officer)
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ID · 7dfb2bbc-9e21-4a41-8994-4dd22463ea97
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1018699
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.30(j)Design history file
- 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 |
|---|---|---|---|
| November 7, 2016 | 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 1003151 - 2016-11-07
- FDA Inspection 834109 - 2013-06-02
- FDA Inspection 741250 - 2011-08-24
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