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1267498

Thera Test Laboratories, Inc. — FEI 1421346

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 21, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Lombard, IL (United States)

Facility

Other inspections at this facility

  • 1146673 (VAI Wed Jul 21 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 993509 (NAI Wed Nov 23 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854253 (NAI Thu Mar 28 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 632340 (NAI Tue Dec 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
226921 CFR 820.20(a)Quality policy and objectives
313021 CFR 820.100(a)Lack of or inadequate procedures
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures
41921 CFR 820.20(b)Lack of or inadequate organizational structure