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AGC Biologics — Bothell

Bothell, Washington, United States · CDMO

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

Site facts

Company
AGC Biologics
Name(s) in FDA data
AGC Biologics, Inc.
FEI number(s)
3000209996 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Bothell, Washington, United States 98021
Records matched
8 FDA inspections
Most recent FDA inspection in dataset
29 May 2026 — NAI

Capabilities (from the company's website)

  • Lyophilization
    …our global center of excellence for formulation, supporting the development of liquid and lyophilized drug products, including high-concentration formulations. This site serves as the hub f…
  • Biologics drug substance
    …Redefining Manufacturing Strategies Listen now! Seattle Site Overview Washington, U.S.A. Mammalian & Microbial Manufacturing Site The Seattle campus has been producing biologics products f…
  • ADCs & bioconjugates
    …eattle site offer? We develop high-performing cell lines for mAbs, bispecific antibodies, ADCs, and other complex proteins, from creation through GMP transfer. Our experienced Seattle…
  • Analytical testing
    …eted proteins, intracellular soluble proteins, and more Protein analytics (GMP), IPC, and release testing Learn more about our global microbial services Seattle Site Development & Quality Service…
  • Formulation & process development
    …capability to learn more: Mammalian Production Microbial Production Cell Line Development Process Development Formulation Development Quality Control Get all the details on this site. Our in-depth fa…

Taken from the company's web page for this site. Source: https://www.agcbio.com/facilities/seattle, 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 May 2026
    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 3000209996, inspection ID 1303206)

  2. 18 Apr 2025
    FDA inspection FDA inspection classified VAI

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

    Source: FDA Data Dashboard – Inspections (FEI 3000209996, inspection ID 1265749)

  3. 10 Feb 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 3000209996, inspection ID 1197098)

  4. 23 Jul 2021
    FDA inspection FDA inspection classified VAI

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

    Source: FDA Data Dashboard – Inspections (FEI 3000209996, inspection ID 1149254)

  5. 15 Oct 2018
    FDA inspection FDA inspection classified VAI

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

    Source: FDA Data Dashboard – Inspections (FEI 3000209996, inspection ID 1109813)

  6. 15 May 2015
    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 3000209996, inspection ID 930335)

  7. 18 Apr 2012
    FDA inspection FDA inspection classified NAI

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

    Source: FDA Data Dashboard – Inspections (FEI 3000209996, inspection ID 779103)

  8. 13 Feb 2009
    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 3000209996, inspection ID 562746)

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.