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CARBOGEN AMCIS — Bubendorf

Bubendorf, Switzerland · CDMO

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

Site facts

Company
CARBOGEN AMCIS
Name(s) in FDA data
Carbogen Amcis AG
FEI number(s)
3000998501 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Bubendorf, Switzerland
Records matched
5 FDA inspections
Most recent FDA inspection in dataset
14 Nov 2025 — VAI

Capabilities (from the company's website)

  • API / drug substance (chemical)
    …Bubendorf, … Bubendorf Development and cGMPmanufacturing of Highly Potent API including Antibody Drug Conjugates (ADC) Our facility located in Bubendorf – a municipali…
  • Highly potent (HPAPI)
    …Bubendorf, … Bubendorf Development and cGMPmanufacturing of Highly Potent API including Antibody Drug Conjugates (ADC) Our facility located in Bubendorf – a munici…
  • ADCs & bioconjugates
    …Bubendorf, … Bubendorf Development and cGMPmanufacturing of Highly Potent API including Antibody Drug Conjugates (ADC) Our facility located in Bubendorf – a municipality in the district of Liestal in t…
  • Formulation & process development
    …has continuously adapted to the changing needs of the pharmaceutical industry. Activities Process optimization and supply of late-phase and commercial APIs Highly potent manufacturing up to 100 kg sca…

Taken from the part of the company's network/locations page that describes this site. Source: https://www.carbogen-amcis.com/locations, 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. 14 Nov 2025
    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 3000998501, inspection ID 1327698)

  2. 16 Dec 2022
    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 3000998501, inspection ID 1195274)

  3. 08 Sep 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 3000998501, inspection ID 1037734)

  4. 14 Mar 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 3000998501, inspection ID 873227)

  5. 29 Sep 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 3000998501, inspection ID 747928)

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.