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Catalent — Malvern

Malvern, Pennsylvania, United States · CDMO

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

Site facts

Company
Catalent
Name(s) in FDA data
Catalent Micron Technologies, Inc.
FEI number(s)
3007992266 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Malvern, Pennsylvania, United States 19355
Records matched
7 FDA inspections
Most recent FDA inspection in dataset
09 Jun 2025 — VAI

Capabilities (from the company's website)

  • Small molecule
    …industry. Contact Us About This Site View Job Openings Facility at a Glance Service Area Small Molecule Facility Type Development Commercialization Certifications Highlights Foreign Trade Zone…
  • API / drug substance (chemical)
    …containment systems, the facility is designed to safely handle cytotoxic and high‑potency APIs while ensuring consistent quality and regulatory compliance. Together, these capabilities…
  • Highly potent (HPAPI)
    …alization. The site provides micronization and milling capabilities for both standard and highly potent compounds, along with integrated material characterization and testing to optimize drug p…
  • Oral solid dose
    …ronization and Milling Small Molecule Commercialization Commercial CGMP Manufacturing for Oral Solid & Liquid Micronization and Milling Quality & Certifications Certifications FDA MHRA EMA P…
  • Spray drying & particle engineering
    …Malvern Pennsylvania, United States Catalent Micron Technologies Malvern facility offers particle engineering services, specializing in particle size reduction technologies and integrated analytical…
  • Analytical testing
    …engineering services, specializing in particle size reduction technologies and integrated analytical services for the pharmaceutical industry. Contact Us About This Site View Job Openings Facility at…
  • Solid-state & particle characterization
    …icron Technologies Malvern facility offers particle engineering services, specializing in particle size reduction technologies and integrated analytical services for the pharmaceutical industry…

Taken from the company's web page for this site. Source: https://www.catalent.com/locations/malvern-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. 09 Jun 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 3007992266, inspection ID 1272162)

  2. 21 Mar 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 3007992266, inspection ID 1089576)

  3. 20 Apr 2016
    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 3007992266, inspection ID 971543)

  4. 12 Jun 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 3007992266, inspection ID 835875)

  5. 08 Dec 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 3007992266, inspection ID 702935)

  6. 31 Mar 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 3007992266, inspection ID 667305)

  7. 23 Feb 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 3007992266, inspection ID 648687)

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.