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883715

Stradis Medical, LLC dba Stradis Healthcare — FEI 1000111025

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 26, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Peachtree Corners, GA (United States)

Facility

Other inspections at this facility

  • 1148060 (VAI Thu Aug 05 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 996163 (NAI Mon Dec 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 770839 (NAI Wed Feb 29 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 719657 (OAI Tue Apr 12 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 593499 (VAI Fri Apr 03 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
343321 CFR 820.75(c)Process changes - review, evaluation and revalidation
53921 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.