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759923

Piezosurgery Inc — FEI 3005282635

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 13, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: 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))
  • 712899 (VAI Tue Mar 01 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
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
232821 CFR 820.22Quality audits - auditor independence
311721 CFR 820.70(i)Software validation for automated processes
313021 CFR 820.100(a)Lack of or inadequate procedures