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Thermo Fisher Scientific (Patheon) — Saint Louis

Saint Louis, Missouri, United States · 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 Biologics LLC
FEI number(s)
3003418999 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Saint Louis, Missouri, United States 63134
Records matched
7 FDA inspections
Most recent FDA inspection in dataset
20 Nov 2024 — VAI

Capabilities (from the company's website)

  • Biologics drug substance
    …g Collaboration Center (BCC) and the Thermo Scientific™ HyPerforma™ DynaDrive™ Single-Use Bioreactors (S.U.B.s). Here our experts have access to high capital equipment and resources, enablin…
  • Formulation & process development
    …to high capital equipment and resources, enabling them to create customized or optimized process development and scale-up techniques for development of bispecific, Fc-fusion, IgG1, IgG4, and various…

Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/st-louis-mo.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. 20 Nov 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 3003418999, inspection ID 1251864)

  2. 08 Dec 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 3003418999, inspection ID 1224734)

  3. 02 Mar 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 3003418999, inspection ID 1200172)

  4. 02 Aug 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 3003418999, inspection ID 1099387)

  5. 21 Feb 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 3003418999, inspection ID 867704)

  6. 03 Apr 2012
    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 3003418999, inspection ID 775547)

  7. 23 Jun 2010
    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 3003418999, inspection ID 669867)

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.