1017642

Sunnex, LLC — FEI 1000583780

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 12, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Charlotte, NC (United States)

Citations

IDCFRDescription
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
315921 CFR 820.184DHR content
330921 CFR 820.120(b)Examination for accuracy
333121 CFR 820.181DMR - not or inadequately maintained
340921 CFR 820.200(d)Service reports
343221 CFR 820.75(b)(2)Documentation of validated process performance
45421 CFR 820.40(a)Document review, approval by designated individual