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1100003

Xodus Medical Inc — FEI 1000221205

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 14, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
New Kensington, PA (United States)

Facility

Other inspections at this facility

  • 1303348 (NAI Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030371 (NAI Tue Oct 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 933965 (NAI Fri Jul 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 819556 (VAI Tue Feb 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 800098 (NAI Fri Sep 21 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
312821 CFR 820.90(a)Nonconforming product control
316821 CFR 820.198(a)Complaints
317221 CFR 820.198(c)Investigation of device failures
328521 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
343321 CFR 820.75(c)Process changes - review, evaluation and revalidation
369621 CFR 820.100(b)Documentation
53721 CFR 820.70(a)Production processes