868220

FUJIFILM Healthcare Manufacturing Corporation Hitachiomiya Office — FEI 3010516924

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 30, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Hitachiomiya (Japan)

Citations

IDCFRDescription
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
315921 CFR 820.184DHR content
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
337521 CFR 820.198(e)Records of complaint investigation