Directory › Thermo Fisher Scientific (Patheon)

Thermo Fisher Scientific (Patheon) — Whitby

Whitby, 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)
3003516812 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Whitby, Canada
Records matched
8 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
17 Feb 2023 — VAI

Capabilities (from the company's website)

  • Oral solid dose
    …Whitby, Ontario Contact us Download fact sheet Oral solid dose Our Whitby Site specializes in commercial manufacturing for a full range of conventi…
  • Clinical trial supply & packaging
    …ities Solid dose manufacturing Controlled substances Bottles, blisters, liquid and sachet packaging Dose forms Tablets Capsules Powders/granules Solutions /Suspensions Technologies High and…
  • Controlled substances
    …nsfer experience for a variety of product types, including: Explosion-proof manufacturing Controlled substances Solvent granulation Powder filling Commercial Services at Whitby Capabilities Solid dose…

Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/whitby-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. 17 Feb 2023
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.165(a): Testing and release for distribution

    Source: FDA Data Dashboard – Citations (FEI 3003516812, inspection ID 1198322)

  2. 17 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 3003516812, inspection ID 1198322)

  3. 14 Sep 2018
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.192: Written record of investigation incomplete
    • 21 CFR 211.67(b): Written procedures fail to include
    • 21 CFR 211.84(d)(1): Component identity verification

    Source: FDA Data Dashboard – Citations (FEI 3003516812, inspection ID 1065689)

  4. 14 Sep 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 3003516812, inspection ID 1065689)

  5. 09 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 3003516812, inspection ID 1002468)

  6. 26 Feb 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 3003516812, inspection ID 976246)

  7. 04 Apr 2014
    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 3003516812, inspection ID 878561)

  8. 24 May 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 3003516812, inspection ID 836167)

  9. 07 Jul 2011
    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 3003516812, inspection ID 734601)

  10. 27 Jan 2009
    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 3003516812, inspection ID 568263)

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.