FDA Inspection
Nexgen SensorsNexgen Sensors – FDA Inspection, Mar 30, 2011
Record Details
This FDA Inspection record concerns Nexgen Sensors, with an inspection on March 30, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nexgen Sensors
- Inspection Date
- March 30, 2011
- Product Type
- Devices
View Company Profile
ID · 64adf387-5cca-46a0-adae-bd36176a036b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 717485
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.80(e)Documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 803.18(a)Event files -- failure to establish and maintain
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.30(g)Design validation - software validation not performed
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