FDA Inspection
Motion View Software LLCMotion View Software LLC – FDA Inspection, Mar 24, 2014
Record Details
This FDA Inspection record concerns Motion View Software LLC, with an inspection on March 24, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Motion View Software LLC
- Inspection Date
- March 24, 2014
- Product Type
- Devices
View Company Profile
ID · ada54bfa-fc95-40f7-922c-4388df20da99
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 867824
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
18- 21 CFR 820.80(e)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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