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FDA-Inspected Site

FUJIFILM Diosynth Biotechnologies Denmark ApS

13 FDA inspections are on record for FUJIFILM Diosynth Biotechnologies Denmark ApS in Hillerod, Denmark.

483· Form 483 issued

Hillerod, Denmark · Last updated July 9, 2026

Overview

  • 13 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-11-12.

At a glance

Inspections

13

Form 483s

8

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 Nov 2024 – 12 Nov 2024Human Drugs483On file
12 Jun 2023 – 30 Jun 2023Human DrugsClean
7 Oct 2019 – 11 Oct 2019Human Drugs483On file
8 May 2019 – 10 May 2019Human DrugsClean
4 Feb 2019 – 12 Feb 2019Human Drugs483On file
9 Apr 2018 – 13 Apr 2018Human Drugs483On file
23 Oct 2017 – 31 Oct 2017Human Drugs483On file
8 Jun 2017 – 16 Jun 2017Human DrugsClean
4 Jul 2016 – 8 Jul 2016Human Drugs483On file
11 Aug 2014 – 19 Aug 2014Human Drugs483On file
6 May 2013 – 13 May 2013Human Drugs483On file
2 Dec 2011Not recordedClean

Investigators

FDA investigators tied to this site in the record.

Zhong Li2 insp.
Richard Ledwidge1 insp.
David D Anderson1 insp.
MRA V MillarW1 insp.
MRA DavisM1 insp.
Bo Chi1 insp.
Michael Shanks1 insp.
Dennis Cantellops Paite1 insp.
Ephrem T Hunde1 insp.
Wayne E Seifert1 insp.
Brandon C Heitmeier1 insp.
Reyes Candau-Chacon1 insp.
Yehualashe A Gessesse1 insp.
Rebecca Rodriguez1 insp.

Full site report

Get the verbatim findings behind FUJIFILM Diosynth Biotechnologies Denmark ApS' 8 Form 483s

The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat