846112

Karl Storz Endovision, Inc. — FEI 1221826

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 26, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Charlton, MA (United States)

Citations

IDCFRDescription
315921 CFR 820.184DHR content
322621 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures