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Thermo Fisher Scientific (Patheon) — Bourgoin Jallieu Cedex

Bourgoin Jallieu Cedex, France · 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 France S.A.S.
FEI number(s)
3004468553 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Bourgoin Jallieu Cedex, France
Records matched
5 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
29 Sep 2023 — VAI

Capabilities (from the company's website)

  • Small molecule
    …our journey to market. Download brochure Whitepaper Expediting early-phase development of small molecules: An integrated approach In this whitepaper, we discuss key strategies for efficiently adv…
  • API / drug substance (chemical)
    …development and commercial manufacturing, with specialized capabilities for high-potency APIs. Contact us Download fact sheet Oral solid dose Key highlights at our Bourgoin site Dry g…
  • Highly potent (HPAPI)
    …al solid dose development and commercial manufacturing, with specialized capabilities for high-potency APIs. Contact us Download fact sheet Oral solid dose Key highlights at our Bourgoin site…
  • Oral solid dose
    …Bourgoin, France: Oral solid dose development and manufacturing facility Supporting early- and late-stage oral solid d…
  • Spray drying & particle engineering
    …ined capabilities for dry and wet granulation, blending, and STYL’ONE EVO compaction. New spray drying capability in R&D Early formulation screening and development solutions for solubilit…
  • Clinical trial supply & packaging
    …tion in handling highly potent APIs up to category 3B, including cytostatic Comprehensive packaging solutions including bottles, blisters, and high-speed lines Versatile manufacturing capab…
  • Formulation & process development
    …e-meter dedicated R&D hub features state-of-the-art equipment and technologies to support formulation development and mature product characterization of oral solid dose forms. Our comprehensive capabilit…

Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/bourgoin-fr.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. 29 Sep 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 3004468553, inspection ID 1267774)

  2. 27 Sep 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 3004468553, inspection ID 1135560)

  3. 08 Jun 2018
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.113(a): Procedures for non-sterile drug products

    Source: FDA Data Dashboard – Citations (FEI 3004468553, inspection ID 1055111)

  4. 08 Jun 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 3004468553, inspection ID 1055111)

  5. 11 Mar 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 3004468553, inspection ID 964412)

  6. 28 Mar 2014
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Devices, Drugs. Project area(s): Compliance: Devices; Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 3004468553, inspection ID 871761)

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.