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Catalent — Harmans

Harmans, 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)
3015434301 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Harmans, Maryland, United States 21077
Records matched
4 FDA inspections
Most recent FDA inspection in dataset
15 Nov 2024 — NAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …viral vectors, adenovirus through fully integrated upstream and downstream manufacturing, aseptic fill/finish and centralized GMP testing. Designed to support both clinical flexibility and com…
  • Biologics drug substance
    …early clinical supply into validated commercial manufacturing. Its large‑scale single‑use bioreactor infrastructure, 16 purpose‑built GMP suites and standardized technology transfer framewor…
  • Cell & gene therapy
    …I Maryland, United States Catalent’s Harmans/BWI, Maryland campus is a purpose‑built CGMP gene therapy manufacturing hub supporting programs from clinical development through commercial suppl…
  • Clinical trial supply & packaging
    …lexibility and commercial robustness, Harmans/BWI enables seamless progression from early clinical supply into validated commercial manufacturing. Its large‑scale single‑use bioreactor infrastru…
  • Analytical testing
    …RepCap and helper plasmids, a fully characterized GMP master cell bank and pre‑qualified analytical methods, reducing complexity and timeline risk. Regulatory Success Harmans/BWI has supported mul…
  • Formulation & process development
    …Plasmids (RepCapExcel) Advanced AAV pHelper Plasmids* UpTempo AAV® Platform IND-Enabling Process Development Gene Therapy Manufacturing Advanced AAV RepCap Plasmids (RepCapExcel) Advanced AAV pHelpe…

Taken from the company's web page for this site. Source: https://www.catalent.com/locations/harmans-bwi-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. 15 Nov 2024
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Human Cellular, Tissue, and Gene Therapies.

    Source: FDA Data Dashboard – Inspections (FEI 3015434301, inspection ID 1252977)

  2. 10 Mar 2023
    FDA inspection FDA inspection classified VAI

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

    Source: FDA Data Dashboard – Inspections (FEI 3015434301, inspection ID 1207147)

  3. 24 Jan 2023
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Human Cellular, Tissue, and Gene Therapies.

    Source: FDA Data Dashboard – Inspections (FEI 3015434301, inspection ID 1197573)

  4. 17 Nov 2021
    FDA inspection FDA inspection classified VAI

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

    Source: FDA Data Dashboard – Inspections (FEI 3015434301, inspection ID 1156961)

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.