FDA Inspection 1061550 — Fujifilm Corporation

Fujifilm Corporation — FEI 3001722928

The FDA completed an inspection of Fujifilm Corporation on July 13, 2018 in Ashigarakami-Gun. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 13, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Ashigarakami-Gun (Japan)

Additional Details

Postmarket Audit Inspections

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures