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Catalent — Winchester

Winchester, Kentucky, United States · CDMO

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

Site facts

Company
Catalent
Name(s) in FDA data
Catalent Pharma Solutions, LLC
FEI number(s)
1000122400 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Winchester, Kentucky, United States 40391
Records matched
10 FDA inspections · 2 inspections with posted 483 citations
Most recent FDA inspection in dataset
22 Apr 2025 — VAI

Capabilities (from the company's website)

  • Small molecule
    …patients. Contact Us About This Site View Job Openings Facility at a Glance Service Area Small Molecule Facility Type Development Manufacturing Commercialization Certifications Highlights FDA M…
  • Oral solid dose
    …Catalent Winchester provides comprehensive commercial manufacturing solutions for complex oral solid dose products at scale. Backed by more than 30 years of experience in product development…
  • Clinical trial supply & packaging
    …ed release oral dose manufacturing, offering fully integrated development, analytical and packaging services. With advanced technologies, deep technical expertise and end-to-end capabilitie…

Taken from the company's web page for this site. Source: https://www.catalent.com/locations/winchester-united-states, 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. 22 Apr 2025
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.192: Investigations of discrepancies, failures
    • 21 CFR 211.67(b): Written procedures not established/followed

    Source: FDA Data Dashboard – Citations (FEI 1000122400, inspection ID 1264863)

  2. 22 Apr 2025
    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 1000122400, inspection ID 1264863)

  3. 11 Jan 2023
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.194(a)(8): Second person sign off

    Source: FDA Data Dashboard – Citations (FEI 1000122400, inspection ID 1195321)

  4. 11 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 1000122400, inspection ID 1195321)

  5. 15 Nov 2017
    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 1000122400, inspection ID 1038136)

  6. 04 May 2017
    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 1000122400, inspection ID 1012414)

  7. 27 Jun 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 1000122400, inspection ID 885092)

  8. 05 Feb 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 1000122400, inspection ID 820796)

  9. 14 Nov 2012
    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 1000122400, inspection ID 810206)

  10. 19 Apr 2012
    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 1000122400, inspection ID 779004)

  11. 21 Apr 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 1000122400, inspection ID 722291)

  12. 09 Dec 2008
    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 1000122400, inspection ID 556932)

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.