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712899

Piezosurgery Inc — FEI 3005282635

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 1, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Hilliard, OH (United States)

Facility

Other inspections at this facility

  • 1017087 (NAI Wed Jun 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 860088 (NAI Mon Dec 16 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 759923 (VAI Tue Dec 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 656861 (OAI Mon Apr 12 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
311721 CFR 820.70(i)Software validation for automated processes
317221 CFR 820.198(c)Investigation of device failures
334521 CFR 820.200(a)Servicing - Lack of or inadequate procedures
383721 CFR 820.25(b)Training records
63121 CFR 803.17(a)(1)Lack of System for Event Evaluations