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FUJIFILM Biotechnologies — Hillerod

Hillerod, Denmark · CDMO

This is a record of what regulators published, not a rating.

Site facts

Company
FUJIFILM Biotechnologies
Name(s) in FDA data
FUJIFILM Diosynth Biotechnologies Denmark ApS
FEI number(s)
3006339887 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Hillerod, Denmark
Records matched
6 FDA inspections
Most recent FDA inspection in dataset
30 Jun 2023 — VAI

Capabilities (from the company's website)

  • Biologics drug substance
    …Danish Kroner) investment announced in 2022, the site will offer a total of 20 X 20,000 L bioreactors for drug substance production complemented by comprehensive drug product and finished go…

Taken from the company's web page for this site. Source: https://fujifilmbiotechnologies.fujifilm.com/cdmo-facilities/denmark/, checked 16 Oct 2026. Quoted text shows the wording each tag is based on.

Regulatory timeline

Newest first. Each entry links to the published source. Inspection classifications: NAI = no action indicated, VAI = voluntary action indicated, OAI = official action indicated (FDA definitions). Posted 483 citations are FDA's short summaries, not the full Form 483.

  1. 30 Jun 2023
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3006339887, inspection ID 1230111)

  2. 10 May 2019
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3006339887, inspection ID 1123030)

  3. 16 Jun 2017
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3006339887, inspection ID 1030379)

  4. 19 Aug 2014
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3006339887, inspection ID 893674)

  5. 02 Dec 2011
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Devices. Project area(s): Compliance: Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3006339887, inspection ID 761546)

  6. 27 May 2011
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3006339887, inspection ID 737746)

This is a record of what regulators published, not a rating. Absence of a record here does not mean no record exists; see methodology for what we check and how records are matched.