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953430

Dartmouth Hitchcock Medical Center — FEI 1270814

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 17, 2015
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Lebanon, NH (United States)

Facility

Other inspections at this facility

  • 1320158 (NAI Mon Apr 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1058369 (NAI Tue Jun 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017963 (NAI Fri May 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 941242 (NAI Tue Aug 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 888655 (VAI Wed Jul 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
63021 CFR 803.17Lack of Written MDR Procedures
64021 CFR 803.18(a)Event files -- failure to establish and maintain
65821 CFR 803.30(a)(2)Report of Serious Injury Within 10 Days