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1163948

X-Cel X-Ray Corp — FEI 1418484

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 4, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Compliance: Devices
Location
Crystal Lake, IL (United States)

Facility

Other inspections at this facility

  • 1102620 (VAI Wed Sep 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015986 (OAI Fri Jun 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 663009 (NAI Fri May 21 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
315921 CFR 820.184DHR content
333121 CFR 820.181DMR - not or inadequately maintained
367421 CFR 820.30(d)Design output - documentation
54621 CFR 820.75(a)Lack of or inadequate process validation