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Aldevron — Prairie Rose

Prairie Rose, North Dakota, United States · CDMO

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

Site facts

Company
Aldevron
Name(s) in FDA data
Aldevron LLC
FEI number(s)
3015047170 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Prairie Rose, North Dakota, United States 58104
Records matched
1 FDA inspection
Most recent FDA inspection in dataset
08 Nov 2024 — NAI

Capabilities (from the company's website)

  • Sterile fill-finish
    …ufacturing of mRNA drug substance and drug product with LNP encapsulation through sterile Fill & Finish cGMP manufacturing of protein Fast Facts (as of the end of 2022) More than 5,000 lots of…
  • Cell & gene therapy
    …uction Aldevron’s Breakthrough Campus serves as HQ and as one of the world’s largest cGMP plasmid DNA manufacturing facilities. Breakthrough has been purpose built with the latest innovat…
  • mRNA & lipid nanoparticles
    …purpose built with the latest innovations and state-of-the-art equipment to produce DNA, mRNA drug substance, mRNA drug product, and protein. We serve thousands of clients, and each p…

Taken from the company's web page for this site. Source: https://www.aldevron.com/facilities/breakthrough-campus-fargo, 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. 08 Nov 2024
    FDA inspection FDA inspection classified NAI

    No Action Indicated (NAI). Product type(s): Biologics. Project area(s): Vaccines and Allergenic Products.

    Source: FDA Data Dashboard – Inspections (FEI 3015047170, inspection ID 1251366)

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.