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Catalent — Strathroy

Strathroy, 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)
3007325436 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Strathroy, Canada
Records matched
4 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
02 May 2025 — 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…
  • Softgels
    …Location Hub Strathroy - Softgel Ontario, Canada Strathroy, Ontario is one of two sites located in Canada offering softgel…
  • 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 solutions spanning formulation development, CGMP manufacturing, analytical testing and customized packaging. With approximately 110,000 sq. ft. of operational space, the si…
  • Formulation & process development
    …softgel technologies, Strathroy delivers fully integrated, end-to-end solutions spanning formulation development, CGMP manufacturing, analytical testing and customized packaging. With approximately 110,…

Taken from the company's web page for this site. Source: https://www.catalent.com/locations/strathroy-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. 02 May 2025
    Form 483 observations 5 posted Form 483 citation(s)

    Citation summaries (5)
    • 21 CFR 211.100(a): Absence of Written Procedures
    • 21 CFR 211.186(b)(9): Complete instructions, procedures, specifications et. al.
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.63: Equipment Design, Size and Location
    • 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenance

    Source: FDA Data Dashboard – Citations (FEI 3007325436, inspection ID 1268776)

  2. 02 May 2025
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.

    Source: FDA Data Dashboard – Inspections (FEI 3007325436, inspection ID 1268776)

  3. 12 Apr 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 3007325436, inspection ID 1090476)

  4. 07 Nov 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 3007325436, inspection ID 906166)

  5. 21 Sep 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 3007325436, inspection ID 748370)

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.