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554460

Addition Technology Inc — FEI 3000309468

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 15, 2008
Fiscal Year
2009
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Lombard, IL (United States)

Additional Details

Postmarket Audit Inspections

Facility

Other inspections at this facility

  • 1204379 (NAI Thu Apr 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029535 (NAI Fri Sep 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 942276 (VAI Fri Sep 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 838149 (VAI Fri Jun 28 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 653684 (NAI Wed Mar 24 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
329121 CFR 820.100(b)Procedures
63021 CFR 803.17Lack of Written MDR Procedures
73221 CFR 803.50(a)(2)Individual Report of Malfunction