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Lonza — Bend

Bend, Oregon, United States · CDMO

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

Site facts

Company
Lonza
Name(s) in FDA data
Lonza Bend Inc.
FEI number(s)
3003722743, 1000656789 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Bend, Oregon, United States 97701
Records matched
9 FDA inspections · 8 inspections with posted 483 citations
Most recent FDA inspection in dataset
19 May 2026 — VAI

Capabilities (from the company's website)

  • Small molecule
    …Skip to main content Compatible state-of-the-art equipment Offerings Small Molecules Offerings Catalog Amorphous Solid Dispersion Technology Improve bioavailability with Lonz…
  • API / drug substance (chemical)
    …E)... Learn more Bioavailability Enhancement We offer integrated product development from active pharmaceutical ingredients through particle-engineered intermediates to finished drug products.... Learn more Spray…
  • Oral solid dose
    …r integrated product development services, we provide commercial scale production for our oral solid products from a global network of... Learn more Design and Preformulation Development Ben…
  • Inhalation & nasal
    …ll molecule applications for early and late-phase clinical trials. Learn more. Learn more Inhalation Formulation Development Benefit from a flexible, integrated inhalation formulation f…
  • Spray drying & particle engineering
    …Improve bioavailability with Lonza’s amorphous solid dispersion CDMO services. Scale your spray-dried dispersion (SDD) or hot-melt extrusion (HME)... Learn more Bioavailability Enhancement…
  • Analytical testing
    …s to determine the right molecule & accelerate entry to market. Learn more Pharmaceutical Method Development Receive end-to-end analytical support in the development of your molecule, bringing your…
  • Formulation & process development
    …production for our oral solid products from a global network of... Learn more Design and Preformulation Development Benefit from access to product design, preformulation and technology expertis…

Taken from the company's web page for this site. Source: https://www.lonza.com/about-us/our-locations/bend-oregon-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. 19 May 2026
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.192: Investigations of discrepancies, failures

    Source: FDA Data Dashboard – Citations (FEI 3003722743, inspection ID 1317820)

  2. 19 May 2026
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.192: Investigations of discrepancies, failures

    Source: FDA Data Dashboard – Citations (FEI 1000656789, inspection ID 1317818)

  3. 19 May 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 1000656789, inspection ID 1317818)

  4. 19 May 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 3003722743, inspection ID 1317820)

  5. 05 Aug 2022
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.166(a): Written program not followed
    • 21 CFR 211.192: Written record of investigation incomplete

    Source: FDA Data Dashboard – Citations (FEI 1000656789, inspection ID 1176638)

  6. 05 Aug 2022
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.192: Extent of discrepancy, failure investigations

    Source: FDA Data Dashboard – Citations (FEI 3003722743, inspection ID 1178398)

  7. 05 Aug 2022
    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 3003722743, inspection ID 1178398)

  8. 05 Aug 2022
    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 1000656789, inspection ID 1176638)

  9. 21 Jul 2017
    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 3003722743, inspection ID 1018924)

  10. 30 Jun 2017
    Form 483 observations 3 posted Form 483 citation(s)

    Citation summaries (3)
    • 21 CFR 211.160(b): Scientifically sound laboratory controls
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.42(c)(9): Control / Lab Operations Area

    Source: FDA Data Dashboard – Citations (FEI 1000656789, inspection ID 1016970)

  11. 30 Jun 2017
    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 1000656789, inspection ID 1016970)

  12. 03 Jun 2016
    Form 483 observations 1 posted Form 483 citation(s)

    Citation summaries (1)
    • 21 CFR 211.94(b): Protection from external factors

    Source: FDA Data Dashboard – Citations (FEI 3003722743, inspection ID 985217)

  13. 03 Jun 2016
    Form 483 observations 7 posted Form 483 citation(s)

    Citation summaries (7)
    • 21 CFR 211.192: Extent of discrepancy, failure investigations
    • 21 CFR 211.198(a): Quality Control Review
    • 21 CFR 211.22(a): Authority lacking to review records, investigate errors
    • 21 CFR 211.22(d): Procedures not in writing, fully followed
    • 21 CFR 211.25(a): Training--operations, GMPs, written procedures
    • 21 CFR 211.68(b): Computer control of master formula records
    • 21 CFR 211.94(b): Protection from external factors

    Source: FDA Data Dashboard – Citations (FEI 3003722743, inspection ID 985219)

  14. 03 Jun 2016
    Form 483 observations 4 posted Form 483 citation(s)

    Citation summaries (4)
    • 21 CFR 211.160(a): Lab controls established, including changes
    • 21 CFR 211.192: Extent of discrepancy, failure investigations
    • 21 CFR 211.22(c): Approve or reject procedures or specs
    • 21 CFR 211.68(b): Computer control of master formula records

    Source: FDA Data Dashboard – Citations (FEI 1000656789, inspection ID 985218)

  15. 03 Jun 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 1000656789, inspection ID 985218)

  16. 03 Jun 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 3003722743, inspection ID 985217)

  17. 03 Jun 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 3003722743, inspection ID 985219)

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.