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FDA Inspection 1230111 — FUJIFILM Diosynth Biotechnologies Denmark ApS

FUJIFILM Diosynth Biotechnologies Denmark ApS — FEI 3006339887

The FDA completed an inspection of FUJIFILM Diosynth Biotechnologies Denmark ApS on June 30, 2023 in Hillerod. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 30, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hillerod (Denmark)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1123030 (VAI Fri May 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030379 (NAI Fri Jun 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 893674 (VAI Tue Aug 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 761546 (NAI Fri Dec 02 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 737746 (NAI Fri May 27 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources