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1146673

Thera Test Laboratories, Inc. — FEI 1421346

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 21, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Compliance: Devices
Location
Lombard, IL (United States)

Facility

Other inspections at this facility

  • 1267498 (VAI Mon Apr 21 2025 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
312721 CFR 820.80(e)Documentation
315921 CFR 820.184DHR content
333121 CFR 820.181DMR - not or inadequately maintained
342621 CFR 820.50(a)(1)Documented evaluation
419121 CFR 806.10(a)(1)Report of risk to health