Directory › Thermo Fisher Scientific (Patheon)

Thermo Fisher Scientific (Patheon) — Tilburg

Tilburg, Netherlands · 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 Softgels B.V.
FEI number(s)
1000384811 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Tilburg, Netherlands
Records matched
4 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
17 May 2023 — VAI

Capabilities (from the company's website)

  • Softgels
    …Tilburg, Netherlands Contact us Download fact sheet Softgels Our Tillburg, NL facility offers commercial manufacturing and development of gelatin base…
  • Clinical trial supply & packaging
    …Prescription(Rx), Over-The-Counter (OTC) and Nutraceutical dosage forms Manufacturing of clinical supplies Manufacturing with use of specific proprietary softgel technologies (e.g. Chewels, Liq…
  • Analytical testing
    …or various dosage forms Taste masking development for chewable dosage forms Formulation & analytical development for low solubility compounds; Solubility screening Development and small-scale manufactur…
  • Formulation & process development
    …iety of softgel technologies. Specialized Capabilities Product development expertise from pre-formulation into commercial product for Prescription(Rx), Over-The-Counter (OTC) and Nutraceutical do…

Taken from the company's web page for this site. Source: https://www.patheon.com/us/en/site-locations/tilburg-nl.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 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 1000384811, inspection ID 1261181)

  2. 30 Nov 2018
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.160(a): Lab controls established, including changes
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.68(b): Computer control of master formula records

    Source: FDA Data Dashboard – Citations (FEI 1000384811, inspection ID 1073073)

  3. 30 Nov 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 1000384811, inspection ID 1073073)

  4. 20 Jun 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 1000384811, inspection ID 885869)

  5. 14 Mar 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 1000384811, inspection ID 774336)

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.