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1150957

Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. — FEI 3002698769

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 7, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Compliance: Devices
Location
Whitestown, IN (United States)

Facility

Other inspections at this facility

  • 1197996 (NAI Mon Jan 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1080894 (OAI Fri Feb 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 889994 (NAI Thu Aug 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 791491 (VAI Fri Jul 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 597917 (NAI Wed Jul 22 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation