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Catalent — Baltimore

Baltimore, Maryland, United States · CDMO

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

Site facts

Company
Catalent
Name(s) in FDA data
Catalent Maryland, Inc.
FEI number(s)
3015558590 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Baltimore, Maryland, United States 21201
Records matched
2 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
09 Apr 2025 — VAI

Capabilities (from the company's website)

  • Cell & gene therapy
    …altimore BioPark site is a dedicated process and analytical development center supporting gene therapy programs from early development through GMP readiness. The site focuses on building robu…
  • Analytical testing
    …Park Maryland, United States Catalent’s Baltimore BioPark site is a dedicated process and analytical development center supporting gene therapy programs from early development through GMP readiness. The…
  • Formulation & process development
    …lude both plasmids and viral vectors, and the site specializes in upstream and downstream process development, analytical method development and qualification, scale‑down modeling, process characteri…

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

    Citation summaries (2)
    • 21 CFR 211.113(b): Procedures for sterile drug products
    • 21 CFR 211.58: Buildings not maintained in good state of repair

    Source: FDA Data Dashboard – Citations (FEI 3015558590, inspection ID 1256114)

  2. 09 Apr 2025
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Human Cellular, Tissue, and Gene Therapies.

    Source: FDA Data Dashboard – Inspections (FEI 3015558590, inspection ID 1256114)

  3. 04 Nov 2019
    FDA inspection FDA inspection classified VAI

    Voluntary Action Indicated (VAI). Product type(s): Biologics. Project area(s): Human Cellular, Tissue, and Gene Therapies.

    Source: FDA Data Dashboard – Inspections (FEI 3015558590, inspection ID 1112131)

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.