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1093192

Healgen Scientific LLC — FEI 3003204823

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 13, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Swedesboro, NJ (United States)

Facility

Other inspections at this facility

  • 1296424 (NAI Mon Dec 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945550 (NAI Thu Oct 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 820050 (NAI Fri Mar 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 701533 (VAI Thu Dec 23 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation