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1195256

Genesis Biosystems, Inc — FEI 3003427273

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 9, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Lewisville, TX (United States)

Facility

Other inspections at this facility

  • 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))
  • 908043 (OAI Tue Dec 16 2014 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
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1472021 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
232821 CFR 820.22Quality audits - auditor independence