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Catalent — Morrisville

Morrisville, 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 Pharma Solutions LLC
FEI number(s)
1000110912 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Morrisville, North Carolina, United States 27560
Records matched
12 FDA inspections · 5 inspections with posted 483 citations
Most recent FDA inspection in dataset
22 May 2026 — VAI

Capabilities (from the company's website)

  • Small molecule
    …products. 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…
  • Inhalation & nasal
    …h Carolina, United States Catalent’s Morrisville facility is our Center of Excellence for nasal development and manufacturing, delivering end‑to‑end support from formulation through cli…
  • Spray drying & particle engineering
    …ization, method services and analytical testing. Specialized equipment includes a Procept Spray Dryer, GEA blenders, Harro Höfliger drum labs and advancing testing equipment. With analytic…
  • Analytical testing
    …ulmonary products including formulation development and optimization, method services and analytical testing. Specialized equipment includes a Procept Spray Dryer, GEA blenders, Harro Höfliger drum…
  • Formulation & process development
    …also provides development services for dry powder and liquid pulmonary products including formulation development and optimization, method services and analytical testing. Specialized equipment includes…

Taken from the company's web page for this site. Source: https://www.catalent.com/locations/morrisville-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 May 2026
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.67(b): Written procedures not established/followed

    Source: FDA Data Dashboard – Citations (FEI 1000110912, inspection ID 1303072)

  2. 22 May 2026
    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 1000110912, inspection ID 1303072)

  3. 24 May 2024
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.67(a): Cleaning / Sanitizing / Maintenance

    Source: FDA Data Dashboard – Citations (FEI 1000110912, inspection ID 1229061)

  4. 24 May 2024
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Blood and Blood Products.

    Source: FDA Data Dashboard – Inspections (FEI 1000110912, inspection ID 1229061)

  5. 15 Dec 2022
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.160(a): Following/documenting laboratory controls
    • 21 CFR 211.160(b)(4): Establishment of calibration procedures
    • 21 CFR 211.165(e): Test methods
    • 21 CFR 211.167(a): Sterility/pyrogens - test methods written, followed

    Source: FDA Data Dashboard – Citations (FEI 1000110912, inspection ID 1195585)

  6. 15 Dec 2022
    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 1000110912, inspection ID 1195585)

  7. 28 Sep 2020
    Form 483 observations 5 posted Form 483 citation(s)

    Citation summaries (5)
    • 21 CFR 820.30(b): Design plans - Lack of or inadequate
    • 21 CFR 820.30(c): Design input - Lack of or inadequate procedures
    • 21 CFR 820.30(d): Design output - Lack of or inadequate procedures
    • 21 CFR 820.30(f): Design verification - Lack of or inadequate procedures
    • 21 CFR 820.30(g): Design validation- Lack of or inadequate procedures

    Source: FDA Data Dashboard – Citations (FEI 1000110912, inspection ID 1131607)

  8. 28 Sep 2020
    FDA inspection FDA inspection classified OAI

    Official Action Indicated (OAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.

    Source: FDA Data Dashboard – Inspections (FEI 1000110912, inspection ID 1131607)

  9. 20 Dec 2019
    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 1000110912, inspection ID 1116748)

  10. 04 Mar 2019
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). 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 1000110912, inspection ID 1081169)

  11. 01 Feb 2019
    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 1000110912, inspection ID 1086471)

  12. 19 May 2017
    Form 483 observations 2 posted Form 483 citation(s)

    Citation summaries (2)
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.42(c)(8): Released Drug Products Area

    Source: FDA Data Dashboard – Citations (FEI 1000110912, inspection ID 1014725)

  13. 19 May 2017
    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 1000110912, inspection ID 1014725)

  14. 20 Mar 2015
    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 1000110912, inspection ID 919124)

  15. 14 Feb 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 1000110912, inspection ID 818956)

  16. 11 Nov 2010
    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 1000110912, inspection ID 699296)

  17. 18 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 1000110912, inspection ID 634689)

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.