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Thermo Fisher Scientific (Patheon) — Carrigaline

Carrigaline, Ireland · CDMO

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

Site facts

Company
Thermo Fisher Scientific (Patheon)
Name(s) in FDA data
Thermo Fisher Scientific Cork Limited
FEI number(s)
1000170338 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Carrigaline, Ireland
Records matched
6 FDA inspections · 1 warning letter
Most recent FDA inspection in dataset
07 Sep 2022 — VAI

Capabilities (from the company's website)

  • Small molecule
    …r, cleaner, and safer through API development and manufacturing . Site offerings Flexible small molecule API process development, scale-up, and commercialization all within one integrated, FDA-i…
  • API / drug substance (chemical)
    …Cork, Ireland Active pharmaceutical ingredient (API) development and manufacturing Contact us Request a site tour Active pharmaceutical…
  • Highly potent (HPAPI)
    …phases of development and commercialization A center of excellence for the manufacture of highly potent APIs Capabilities This site provides flexible and multipurpose facilities, including thes…
  • Spray drying & particle engineering
    …ic tones Range of milling options including air classifier, pin, and hammer mills Aqueous spray drying Learn more about the specific equipment and capabilities at this site by downloading…
  • Clinical trial supply & packaging
    …nd polymorph screening at early stages of clinical trials to ensure scalability for early clinical supplies to commercial manufacturing. Watch webinar White paper Advancing drug development usin…
  • Analytical testing
    …inging medicines to patients through the relentless application of science in process and analytical development. We take chemistry from laboratory-scale development through to large-scale commercial su…
  • Solid-state & particle characterization
    …tical method development and validation Process validation, optimization, and development Solid state assessment New process technology transfer and evaluation Manufacturing of API and regist…
  • Formulation & process development
    …er through API development and manufacturing . Site offerings Flexible small molecule API process development, scale-up, and commercialization all within one integrated, FDA-inspected facility Fully…

Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/cork-ireland.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. 07 Sep 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 1000170338, inspection ID 1271628)

  2. 26 Jul 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 1000170338, inspection ID 1118946)

  3. 26 Jan 2017
    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 1000170338, inspection ID 1000860)

  4. 01 May 2015
    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 1000170338, inspection ID 928298)

  5. 18 Mar 2014
    Warning letter FDA warning letter (Drugs)

    Compliance action recorded by FDA for FEI 1000170338; case/injunction ID 416184.

    Source: FDA Data Dashboard – Compliance Actions (FEI 1000170338, case 416184)

  6. 23 Oct 2013
    FDA inspection FDA inspection classified OAI

    Official Action Indicated (OAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 1000170338, inspection ID 853107)

  7. 10 Sep 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 1000170338, inspection ID 618268)

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.