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Catalent — Windsor

Windsor, Canada · CDMO

This is a record of what regulators published, not a rating.

Site facts

Company
Catalent
Name(s) in FDA data
Catalent Ontario Limited
FEI number(s)
3000118564 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Windsor, Canada
Records matched
7 FDA inspections · 3 inspections with posted 483 citations
Most recent FDA inspection in dataset
20 Jan 2023 — VAI

Capabilities (from the company's website)

  • Small molecule
    …solutions. Contact Us About This Site View Job Openings Facility at a Glance Service Area Small Molecule OTC Dietary Supplements Facility Type Development Manufacturing Commercialization Innovat…
  • Highly potent (HPAPI)
    …ional space, the site is equipped to deliver both Rx and OTC softgel solutions, including high-potency capabilities supported by robust quality control and microbiology laboratories. Leveragin…
  • Softgels
    …b Windsor Ontario, Canada Windsor, Ontario is one of two sites located in Canada offering softgel development and manufacturing capabilities for the Pharmaceutical and Consumer Health ind…
  • Clinical trial supply & packaging
    …ndustries. We have a broad range of integrated formulation, manufacturing, analytical and packaging services to offer full-service turnkey solutions. Contact Us About This Site View Job Ope…
  • Analytical testing
    …ly integrated, end-to-end services spanning formulation, compounding, CGMP manufacturing, analytical testing and finished product packaging. With approximately 120,000 sq. ft. of operational space,…
  • Microbiology
    …el solutions, including high-potency capabilities supported by robust quality control and microbiology laboratories. Leveraging Catalent’s proprietary RP Scherer® softgel technology, the Wind…

Taken from the company's web page for this site. Source: https://www.catalent.com/locations/windsor-canada, 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. 20 Jan 2023
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.170(b): Drug product reserve containers

    Source: FDA Data Dashboard – Citations (FEI 3000118564, inspection ID 1195280)

  2. 20 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 3000118564, inspection ID 1195280)

  3. 08 Feb 2019
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.160(b)(1): Specification description of sample/testing
    • 21 CFR 211.68(a): Calibration/Inspection/Checking not done

    Source: FDA Data Dashboard – Citations (FEI 3000118564, inspection ID 1079817)

  4. 08 Feb 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 3000118564, inspection ID 1079817)

  5. 29 Jun 2018
    FDA inspection FDA inspection classified OAI

    Official Action Indicated (OAI). Product type(s): Drugs. Project area(s): Bioresearch Monitoring.

    Source: FDA Data Dashboard – Inspections (FEI 3000118564, inspection ID 1064352)

  6. 18 Sep 2015
    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 3000118564, inspection ID 945638)

  7. 06 Sep 2013
    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 3000118564, inspection ID 849512)

  8. 16 Sep 2011
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.84(c)(4): Top/Middle/Bottom container sampling
    • 21 CFR 211.84(d)(1): Component identity verification
    • 21 CFR 211.84(d)(2): Component written specification

    Source: FDA Data Dashboard – Citations (FEI 3000118564, inspection ID 748354)

  9. 16 Sep 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 3000118564, inspection ID 748354)

  10. 14 Aug 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 3000118564, inspection ID 606805)

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.