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1013534

Bionica Inc. — FEI 3004435660

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 9, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Mcclellan, CA (United States)

Facility

Other inspections at this facility

  • 1061626 (NAI Mon Jul 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 901734 (NAI Tue Oct 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 633383 (NAI Thu Dec 03 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1471821 CFR 820.30(g)Design validation - Risk analysis
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures