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FUJIFILM Biotechnologies — Billingham

Billingham, United Kingdom · 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 UK Limited
FEI number(s)
3007182567 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Billingham, United Kingdom
Records matched
6 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
17 Mar 2023 — VAI

Capabilities (from the company's website)

  • Formulation & process development
    …content Billingham, United Kingdom Previous Next People The Billingham site serves as our process development and microbial center of excellence and is home to Borealis, the largest single-use CDMO f…

Taken from the company's web page for this site. Source: https://fujifilmbiotechnologies.fujifilm.com/cdmo-facilities/uk/billingham/, 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. 17 Mar 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 3007182567, inspection ID 1200417)

  2. 25 Mar 2021
    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 3007182567, inspection ID 1155694)

  3. 16 Nov 2018
    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 3007182567, inspection ID 1097949)

  4. 11 Jul 2014
    Form 483 observations 5 posted Form 483 citation(s)

    Citation summaries (5)
    • 21 CFR 211.110(a): Control procedures to monitor and validate performance
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.22(c): Approve or reject procedures or specs
    • 21 CFR 211.25(a): Training--operations, GMPs, written procedures
    • 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenance

    Source: FDA Data Dashboard – Citations (FEI 3007182567, inspection ID 894612)

  5. 11 Jul 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 3007182567, inspection ID 894612)

  6. 20 Jun 2012
    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 3007182567, inspection ID 790405)

  7. 09 Jan 2009
    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 3007182567, inspection ID 559762)

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.