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Lonza — Portsmouth

Portsmouth, New Hampshire, United States · CDMO

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

Site facts

Company
Lonza
Name(s) in FDA data
Lonza Biologics, Inc.
FEI number(s)
3001451441 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Portsmouth, New Hampshire, United States 03801
Records matched
9 FDA inspections
Most recent FDA inspection in dataset
06 Feb 2026 — VAI

Capabilities (from the company's website)

  • Biologics drug substance
    …vel biopharmaceutical production Lonza Portsmouth specializes in the custom production of mammalian biopharmaceuticals and cell therapies. With the market for these drugs expanding rapidly,…
  • Cell & gene therapy
    …Lonza Portsmouth specializes in the custom production of mammalian biopharmaceuticals and cell therapies. With the market for these drugs expanding rapidly, pharma and biotech companies face…
  • Microbiology
    …and autologous cell therapy cGMP manufacturing Approximately 25,000 ft2 Dedicated QC and environmental monitoring labs Additional space available for expansion In the community Our employee engagement in…
  • Formulation & process development
    …om manufacture of mammalian biopharmaceuticals Regulatory support Large-scale manufacture Process development and process validation Large and flexible mammalian capacity 20,000L commercial manufactu…

Taken from the company's web page for this site. Source: https://www.lonza.com/about-us/our-locations/portsmouth-nh-usa, 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. 06 Feb 2026
    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 3001451441, inspection ID 1304046)

  2. 07 Mar 2024
    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 3001451441, inspection ID 1232144)

  3. 21 Jul 2023
    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 3001451441, inspection ID 1210690)

  4. 21 Sep 2017
    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 3001451441, inspection ID 1028939)

  5. 26 Aug 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 3001451441, inspection ID 988692)

  6. 10 Feb 2015
    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 3001451441, inspection ID 914920)

  7. 30 Sep 2013
    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 3001451441, inspection ID 850896)

  8. 21 Apr 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 3001451441, inspection ID 659362)

  9. 03 Sep 2009
    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 3001451441, inspection ID 611071)

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.