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Minaris — Allendale

Allendale, New Jersey, United States · CDMO

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

Site facts

Company
Minaris
Name(s) in FDA data
Minaris Regenerative Medicine, LLC
FEI number(s)
3003407523 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Allendale, New Jersey, United States 07401
Records matched
4 FDA inspections · 1 inspection with posted 483 citations
Most recent FDA inspection in dataset
29 Sep 2025 — VAI

Capabilities (from the company's website)

  • Cell & gene therapy
    …Allendale, New Jersey Description Highlights Founded as Progenitor Cell Therapy in 1999, the Allendale site boasts over 25 years of experience in cell and gene therapy…
  • Microbiology
    …ts first commercial run. 10 Grade B clean rooms 2 process development labs Analytical and microbiology labs Approved for commercial production … Allendale site boasts over 25 years of experi…
  • Formulation & process development
    …or commercial production and completed its first commercial run. 10 Grade B clean rooms 2 process development labs Analytical and microbiology labs Approved for commercial production … Allendale sit…

Taken from the part of the company's network/locations page that describes this site. Source: https://minaris.com/global-footprint-for-local-manufacture/, 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. 29 Sep 2025
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.100(a): Absence of Written Procedures
    • 21 CFR 211.188(b)(2): Identity of major equipment and lines used
    • 21 CFR 314.80(b): Failure to develop written procedures

    Source: FDA Data Dashboard – Citations (FEI 3003407523, inspection ID 1284408)

  2. 29 Sep 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 3003407523, inspection ID 1284408)

  3. 26 Aug 2019
    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 3003407523, inspection ID 1101234)

  4. 26 Apr 2017
    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 3003407523, inspection ID 1020396)

  5. 17 Jun 2014
    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 3003407523, inspection ID 886646)

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.