Directory › Thermo Fisher Scientific (Patheon)

Thermo Fisher Scientific (Patheon) — Swindon

Swindon, United Kingdom · 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 UK Limited
FEI number(s)
3002807216 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Swindon, United Kingdom
Records matched
8 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
07 Jul 2026 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …s Download fact sheet Steriles Thermo Fisher’s Swindon facility specializes in integrated sterile liquid and lyophilized product development and commercial manufacturing, including high potency…
  • Lyophilization
    …et Steriles Thermo Fisher’s Swindon facility specializes in integrated sterile liquid and lyophilized product development and commercial manufacturing, including high potency products and L…
  • Highly potent (HPAPI)
    …terile liquid and lyophilized product development and commercial manufacturing, including high potency products and LVP. The Swindon facility offers extensive development and commercial capabi…
  • mRNA & lipid nanoparticles
    …rcial supply of novel dosage Facility design and build for unique manufacturing processes LNP capabilities Process development including mRNA Engineering/process expertise Extensive c…
  • Clinical trial supply & packaging
    …dosage forms, including liquid vials, commercial fill finish lines, primary and secondary packaging vials. The facility has: 2 x liquid vial filling lines 1 x liquid vial filling line with…
  • Analytical testing
    …ycle by dosage form: Early Development Late dev Commercial supply Formulation Development Analytical Development Phase l Phase ll Phase lll Commercial scale up Tech transfer Regulatory Liquid vials ⬤ ⬤…
  • Formulation & process development
    …ovel dosage Facility design and build for unique manufacturing processes LNP capabilities Process development including mRNA Engineering/process expertise Extensive complex Technology Transfer experi…

Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/swindon-uk.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 Jul 2026
    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 3002807216, inspection ID 1324282)

  2. 17 Sep 2021
    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 3002807216, inspection ID 1197197)

  3. 01 Mar 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 3002807216, inspection ID 1098252)

  4. 08 May 2015
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.42(c)(10)(iv): Environmental Monitoring System
    • 21 CFR 211.94(a): Reactive/Additive/Absorptive Containers/Closures

    Source: FDA Data Dashboard – Citations (FEI 3002807216, inspection ID 929872)

  5. 08 May 2015
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Pre-Approval Eval. of Animal Drugs and Food Additives.

    Source: FDA Data Dashboard – Inspections (FEI 3002807216, inspection ID 929872)

  6. 12 Sep 2014
    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: Investigations of discrepancies, failures
    • 21 CFR 211.192: Written record of investigation incomplete
    • 21 CFR 211.42(c)(10)(v): Cleaning System

    Source: FDA Data Dashboard – Citations (FEI 3002807216, inspection ID 897644)

  7. 12 Sep 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 3002807216, inspection ID 897644)

  8. 20 Jul 2012
    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 3002807216, inspection ID 793592)

  9. 24 Jun 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 3002807216, inspection ID 594562)

  10. 09 Dec 2008
    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 3002807216, inspection ID 558327)

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.