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AGC Biologics — Soborg

Soborg, Denmark · CDMO

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

Site facts

Company
AGC Biologics
Name(s) in FDA data
AGC Biologics A/S
FEI number(s)
3004708748 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Soborg, Denmark
Records matched
3 FDA inspections
Most recent FDA inspection in dataset
29 Jun 2023 — VAI

Capabilities (from the company's website)

  • Biologics drug substance
    …p Trap - Redefining Manufacturing Strategies Listen now! Copenhagen Site Overview Denmark Mammalian & Microbial Manufacturing in Europe Our AGC Biologics Copenhagen site is one of the large…
  • Formulation & process development
    …e , with extensive cGMP manufacturing experience, from E. coli to yeasts. Global Overview Process Development Full development service from lab development to commercial production including process…

Taken from the company's web page for this site. Source: https://www.agcbio.com/facilities/copenhagen, 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. 29 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 3004708748, inspection ID 1316666)

  2. 22 Apr 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 3004708748, inspection ID 1203574)

  3. 07 Nov 2017
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Blood and Blood Products.

    Source: FDA Data Dashboard – Inspections (FEI 3004708748, inspection ID 1043275)

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.