Directory › Thermo Fisher Scientific (Patheon)

Thermo Fisher Scientific (Patheon) — Mississauga

Mississauga, Canada · 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 Inc.
FEI number(s)
3000264888 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Mississauga, Canada
Records matched
7 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
24 Feb 2023 — VAI

Capabilities (from the company's website)

  • Highly potent (HPAPI)
    …GMP and GMP Work. Our experts at the Toronto facility are ready to address your needs for highly potent, low potent, complex formulations, pediatric dosage forms, patent-extension strategies, a…
  • Oral solid dose
    …Toronto, Ontario Contact us Download fact sheet Oral solid dose Our Toronto facility covers all phases of drug product development from early-phase…
  • Formulation & process development
    …dose Our Toronto facility covers all phases of drug product development from early-phase formulation development to clinical trial material to commercial supply in the same plant using scalable equipmen…

Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/toronto-on.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. 24 Feb 2023
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.192: Written record of investigation incomplete

    Source: FDA Data Dashboard – Citations (FEI 3000264888, inspection ID 1198323)

  2. 24 Feb 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 3000264888, inspection ID 1198323)

  3. 12 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 3000264888, inspection ID 1088856)

  4. 02 Dec 2016
    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 3000264888, inspection ID 999714)

  5. 13 Nov 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 3000264888, inspection ID 948787)

  6. 30 Jan 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 3000264888, inspection ID 915483)

  7. 26 Apr 2013
    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 3000264888, inspection ID 840699)

  8. 18 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 3000264888, inspection ID 713396)

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.