1102620

X-Cel X-Ray Corp — FEI 1418484

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 18, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Radiation Control and Health Safety Act
Location
Crystal Lake, IL (United States)

Citations

IDCFRDescription
310421 CFR 820.30(j)Design history file
316821 CFR 820.198(a)Complaints
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
333121 CFR 820.181DMR - not or inadequately maintained
368621 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}