Directory › Thermo Fisher Scientific (Patheon)

Thermo Fisher Scientific (Patheon) — Linz

Linz, Austria · CDMO

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

Site facts

Company
Thermo Fisher Scientific (Patheon)
Name(s) in FDA data
Patheon Austria GmbH & Co. KG
FEI number(s)
3002806853 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Linz, Austria
Records matched
5 FDA inspections
Most recent FDA inspection in dataset
12 Sep 2024 — VAI

Capabilities (from the company's website)

  • Small molecule
    …tures over 40 science, healthcare, and pharmaceutical companies. Specialized Capabilities Small molecule and polymer API production for clinical and commercial materials (cGMP, Halal, Kosher) Pr…
  • API / drug substance (chemical)
    …Linz, Austria Contact us Download fact sheet Active pharmaceutical ingredient (API) Our Linz facility provides process development and chemical production of intermedi…
  • Analytical testing
    …lity by Design) Process development from early clinical phase up to commercial production Analytical method development and phase appropriate method validations Proven Acceptable Range (PAR), proce…
  • Solid-state & particle characterization
    …validations Proven Acceptable Range (PAR), process safety studies, stability studies and solid state investigations Micro reactors/flow chemistry for developmental quantities and commercial…
  • Formulation & process development
    …us Download fact sheet Active pharmaceutical ingredient (API) Our Linz facility provides process development and chemical production of intermediates and APIs for clinical and commercial supply unde…

Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/linz-at.html, 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. 12 Sep 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 3002806853, inspection ID 1279175)

  2. 30 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 3002806853, inspection ID 1098613)

  3. 29 May 2015
    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 3002806853, inspection ID 932720)

  4. 01 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 3002806853, inspection ID 794147)

  5. 08 May 2009
    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 3002806853, inspection ID 586472)

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.