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908043

Genesis Biosystems, Inc — FEI 3003427273

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 16, 2014
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Lewisville, TX (United States)

Facility

Other inspections at this facility

  • 1195256 (VAI Mon Jan 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028385 (VAI Thu Aug 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 928343 (OAI Mon Jun 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 838279 (NAI Thu Jun 27 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
311721 CFR 820.70(i)Software validation for automated processes
331321 CFR 820.120(d)Records, DHR {see also 820.184(e)}
369621 CFR 820.100(b)Documentation