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1080529

National Biological Corp — FEI 1521608

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 14, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Beachwood, OH (United States)

Facility

Other inspections at this facility

  • 1149180 (VAI Wed Aug 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120770 (NAI Fri Mar 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006563 (OAI Mon Mar 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 836484 (VAI Thu Apr 04 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 628531 (NAI Fri Nov 13 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
54621 CFR 820.75(a)Lack of or inadequate process validation