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Catalent — Greenville

Greenville, North Carolina, United States · CDMO

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

Site facts

Company
Catalent
Name(s) in FDA data
Catalent Greenville Inc
FEI number(s)
3000209735 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Greenville, North Carolina, United States 27834
Records matched
13 FDA inspections · 3 inspections with posted 483 citations
Most recent FDA inspection in dataset
24 Oct 2025 — VAI

Capabilities (from the company's website)

  • Small molecule
    …packaging. Contact Us About This Site View Job Openings Facility at a Glance Service Area Small Molecule Facility Type Development Manufacturing Commercialization Certifications Highlights FDA A…
  • Oral solid dose
    …Location Hub Greenville North Carolina, United States Catalent Greenville is an oral solid dose manufacturing facility providing full service pharmaceutical development, analytical…
  • Clinical trial supply & packaging
    …l service pharmaceutical development, analytical testing and commercial manufacturing and packaging. Contact Us About This Site View Job Openings Facility at a Glance Service Area Small Mol…
  • Analytical testing
    …oral solid dose manufacturing facility providing full service pharmaceutical development, analytical testing and commercial manufacturing and packaging. Contact Us About This Site View Job Openings…
  • Formulation & process development
    …alizes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing and packaging. This state-of-the-art, 333,…

Taken from the company's web page for this site. Source: https://www.catalent.com/locations/greenville-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. 24 Oct 2025
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.165(b): Microbiological testing
    • 21 CFR 211.166(a): Written program not followed
    • 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenance

    Source: FDA Data Dashboard – Citations (FEI 3000209735, inspection ID 1267356)

  2. 24 Oct 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 3000209735, inspection ID 1267356)

  3. 31 Jan 2024
    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 3000209735, inspection ID 1231042)

  4. 12 Jul 2019
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.192: Investigations of discrepancies, failures

    Source: FDA Data Dashboard – Citations (FEI 3000209735, inspection ID 1097051)

  5. 12 Jul 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 3000209735, inspection ID 1097051)

  6. 24 Aug 2018
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Bioresearch Monitoring.

    Source: FDA Data Dashboard – Inspections (FEI 3000209735, inspection ID 1065149)

  7. 13 Apr 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 3000209735, inspection ID 1019260)

  8. 14 Jul 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 3000209735, inspection ID 983236)

  9. 02 May 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 3000209735, inspection ID 880075)

  10. 21 Aug 2013
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Drugs. Project area(s): Bioresearch Monitoring.

    Source: FDA Data Dashboard – Inspections (FEI 3000209735, inspection ID 845560)

  11. 11 May 2012
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.58: Buildings not maintained in good state of repair

    Source: FDA Data Dashboard – Citations (FEI 3000209735, inspection ID 781692)

  12. 11 May 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 3000209735, inspection ID 781526)

  13. 11 May 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 3000209735, inspection ID 781692)

  14. 18 Mar 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 3000209735, inspection ID 713934)

  15. 01 Oct 2010
    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 3000209735, inspection ID 694568)

  16. 13 Nov 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 3000209735, inspection ID 631886)

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.