Home / Inspections / 821760

821760

Hooper Holmes, Inc. — FEI 1000118383

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 7, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Olathe, KS (United States)

Additional Details

Postmarket Audit Inspections

Facility

Other inspections at this facility

  • 1019167 (NAI Wed Jul 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 730902 (VAI Fri Jun 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 719276 (VAI Mon Apr 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 670528 (OAI Wed Jun 23 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
323921 CFR 820.72(b)Remedial action - documentation
383721 CFR 820.25(b)Training records