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1098867

Environmental Tectonics Corp — FEI 2518447

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 1, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Southampton, PA (United States)

Facility

Other inspections at this facility

  • 1201256 (NAI Tue Mar 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 869587 (VAI Tue Mar 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 721361 (VAI Tue Mar 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
2142521 CFR 820.184(f)DHR - UDI not included
315921 CFR 820.184DHR content
320121 CFR 820.40(a)Not approved or obsolete document retrieval
334721 CFR 820.200(c)Service reports/MDRs/complaints
369621 CFR 820.100(b)Documentation
406021 CFR 820.20(b)(3)(i)Management representative implementing the quality system
54621 CFR 820.75(a)Lack of or inadequate process validation