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842491

Vertos Medical, Inc. — FEI 3006450448

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 25, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Aliso Viejo, CA (United States)

Facility

Other inspections at this facility

  • 1205079 (NAI Wed Apr 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122345 (NAI Tue Mar 17 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 992059 (NAI Thu Nov 10 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 586318 (VAI Tue May 26 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
317021 CFR 820.198(b)Review and evaluation for investigation
369621 CFR 820.100(b)Documentation
73221 CFR 803.50(a)(2)Individual Report of Malfunction