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Cambrex — Karlskoga

Karlskoga, Sweden · CDMO

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

Site facts

Company
Cambrex
Name(s) in FDA data
Cambrex Karlskoga AB
FEI number(s)
3001686607 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Karlskoga, Sweden
Records matched
5 FDA inspections
Most recent FDA inspection in dataset
24 May 2024 — VAI

Capabilities (from the company's website)

  • Small molecule
    …t-scale, and large-scale commercial production plants. The site develops and manufactures small molecule APIs, new chemical entities (NCEs), and intermediates from grams to tons, from clinical p…
  • API / drug substance (chemical)
    …ess: SE-691 85 Karlskoga, Sweden Previous Next 1 2 3 4 5 6 7 8 9 10 11 12 Large‑Scale GMP API Manufacturing High‑Potency API Capabilities Clinical Phase II to Commercial High-Energy C…
  • Analytical testing
    …ot plants 6 commercial scale production units 15 production trains Custom development and analytical laboratories cGMP kilo laboratory Strong regulatory history Documentation At Cambrex, sustain…

Taken from the company's web page for this site. Source: https://www.cambrex.com/locations/karlskoga-sweden/, 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. 24 May 2024
    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 3001686607, inspection ID 1273764)

  2. 04 Apr 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 3001686607, inspection ID 1099984)

  3. 27 May 2016
    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 3001686607, inspection ID 973499)

  4. 21 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 3001686607, inspection ID 870565)

  5. 03 Feb 2011
    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 3001686607, inspection ID 711913)

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.