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Catalent — Swindon

Swindon, United Kingdom · CDMO

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

Site facts

Company
Catalent
Name(s) in FDA data
Catalent U.K. Swindon Zydis Limited
FEI number(s)
3003812585 (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
10 Oct 2024 — VAI

Capabilities (from the company's website)

  • Lyophilization
    …folio of Rx and OTC products, including potent and controlled substances. Zydis® ODT is a freeze-dried oral dosage form that dissolves in seconds without water, enhancing patient experience wh…
  • Small molecule
    …to market. Contact Us About This Site View Job Openings Facility at a Glance Service Area Small Molecule OTC Facility Type Development Manufacturing Commercialization Packaging Certifications Hi…
  • Oral solid dose
    …Swindon, UK facility is the global Center of Excellence for Zydis® orally disintegrating tablet (ODT) development and manufacturing. With fully integrated analytical, packaging and regu…
  • Peptides & oligonucleotides
    …l delivery by enabling sublingual and buccal administration of large molecules, including peptides, proteins, vaccines and allergens. Catalent Swindon partners with customers to deliver se…
  • Clinical trial supply & packaging
    …integrating tablet (ODT) development and manufacturing. With fully integrated analytical, packaging and regulatory capabilities, Catalent Swindon enables partners to accelerate development…
  • Formulation & process development
    …® orally disintegrating tablets. Backed by over 40 years of expertise in ODT formulation, process development, scale-up and commercial manufacturing, the site produces approximately 1.2 billion doses…
  • Controlled substances
    …lion doses annually across a broad portfolio of Rx and OTC products, including potent and controlled substances. Zydis® ODT is a freeze-dried oral dosage form that dissolves in seconds without water,…

Taken from the company's web page for this site. Source: https://www.catalent.com/locations/swindon-united-kingdom, 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 Oct 2024
    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 3003812585, inspection ID 1267053)

  2. 15 Jun 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 3003812585, inspection ID 1261182)

  3. 20 Feb 2020
    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 3003812585, inspection ID 1141164)

  4. 26 Jul 2018
    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 3003812585, inspection ID 1064287)

  5. 15 Sep 2016
    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 3003812585, inspection ID 1051240)

  6. 06 Sep 2016
    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 3003812585, inspection ID 990487)

  7. 12 Sep 2014
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.192: Extent of discrepancy, failure investigations
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.28(a): Protective Apparel Not Worn
    • 21 CFR 211.68(a): Written calibration / inspection records not kept

    Source: FDA Data Dashboard – Citations (FEI 3003812585, inspection ID 897773)

  8. 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 3003812585, inspection ID 897773)

  9. 18 Nov 2011
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.100(b): SOPs not followed / documented
    • 21 CFR 211.198(a): Procedures to be written and followed

    Source: FDA Data Dashboard – Citations (FEI 3003812585, inspection ID 759277)

  10. 18 Nov 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 3003812585, inspection ID 759277)

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.