Directory › Thermo Fisher Scientific (Patheon)

Thermo Fisher Scientific (Patheon) — Monza

Monza, Italy · 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 Italia S.p.A.
FEI number(s)
3003065803 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Monza, Italy
Records matched
12 FDA inspections · 5 inspections with posted 483 citations
Most recent FDA inspection in dataset
10 Feb 2026 — VAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …, Italy Contact us Download fact sheet mRNA Steriles Our Monza, Italy site specializes in prefilled syringe and cartridge manufacturing , as well as mRNA drug substance manufacturing and developmen…
  • Lyophilization
    …s (LNP) formulation manufacturing, analytical, and development Prefilled syringes Sterile lyophilized products Sterile liquids (SVP) Cartridges Biopharmaceuticals Controlled drugs Secondary…
  • mRNA & lipid nanoparticles
    …Monza, Italy Contact us Download fact sheet mRNA Steriles Our Monza, Italy site specializes in prefilled syringe and cartridge manufacturi…
  • Clinical trial supply & packaging
    …d products Sterile liquids (SVP) Cartridges Biopharmaceuticals Controlled drugs Secondary packaging (vials) Commercial fill-finish lines Visual Inspection Capabilites 100% automatic visual…
  • Bioanalytical
    …l manufacturing services are fully supported by our comprehensive in-house analytical and bioanalytical capabilities. Additionally, the facility employs Qualified Persons (QPs) to ensure the…

Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/monza-it.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. 10 Feb 2026
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenance

    Source: FDA Data Dashboard – Citations (FEI 3003065803, inspection ID 1304236)

  2. 10 Feb 2026
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Blood and Blood Products; Vaccines and Allergenic Products.

    Source: FDA Data Dashboard – Inspections (FEI 3003065803, inspection ID 1304236)

  3. 29 Sep 2023
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.142: Written warehousing procedures established/followed

    Source: FDA Data Dashboard – Citations (FEI 3003065803, inspection ID 1220064)

  4. 29 Sep 2023
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Vaccines and Allergenic Products.

    Source: FDA Data Dashboard – Inspections (FEI 3003065803, inspection ID 1220064)

  5. 26 May 2023
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.142(b): Storage under appropriate conditions
    • 21 CFR 211.42(c)(10)(iv): Environmental Monitoring System
    • 21 CFR 211.63: Equipment Design, Size and Location

    Source: FDA Data Dashboard – Citations (FEI 3003065803, inspection ID 1206297)

  6. 26 May 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 3003065803, inspection ID 1206297)

  7. 26 Jan 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 3003065803, inspection ID 1238005)

  8. 08 Apr 2022
    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 3003065803, inspection ID 1206091)

  9. 05 Jul 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 3003065803, inspection ID 1130741)

  10. 06 Feb 2018
    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 3003065803, inspection ID 1041862)

  11. 20 May 2016
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.166(b): Adequate number of batches on stability
    • 21 CFR 211.68(b): Computer control of master formula records

    Source: FDA Data Dashboard – Citations (FEI 3003065803, inspection ID 977718)

  12. 20 May 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 3003065803, inspection ID 977718)

  13. 08 Apr 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 3003065803, inspection ID 877083)

  14. 11 Jun 2013
    Form 483 observations 6 posted Form 483 citation(s)

    Citation summaries (6)
    • 21 CFR 211.110(a): Control procedures to monitor and validate performance
    • 21 CFR 211.110(a): Written in-process control procedures
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.122(d): Labels and labeling stored separately
    • 21 CFR 211.192: Written record of investigation incomplete
    • 21 CFR 211.22(d): Procedures not in writing, fully followed

    Source: FDA Data Dashboard – Citations (FEI 3003065803, inspection ID 839378)

  15. 11 Jun 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 3003065803, inspection ID 839378)

  16. 21 Jun 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 3003065803, inspection ID 733806)

  17. 01 Jul 2009
    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 3003065803, inspection ID 600753)

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.