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1024053

Bionix, Llc — FEI 1526854

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 24, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Maumee, OH (United States)

Facility

Other inspections at this facility

  • 1179655 (NAI Fri Sep 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 979145 (NAI Thu Jun 23 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854680 (VAI Thu Nov 21 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 667265 (VAI Thu Jun 17 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1472021 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
313021 CFR 820.100(a)Lack of or inadequate procedures
333121 CFR 820.181DMR - not or inadequately maintained
383721 CFR 820.25(b)Training records