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KBI Biopharma — Boulder

Boulder, Colorado, United States · CDMO

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

Site facts

Company
KBI Biopharma
Name(s) in FDA data
KBI Biopharma, Inc.
FEI number(s)
3011326133 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Boulder, Colorado, United States 80301
Records matched
1 FDA inspection
Most recent FDA inspection in dataset
03 Dec 2021 — VAI

Capabilities (from the company's website)

  • Analytical testing
    …, CO Microbial Cell Line Development leveraging KBI PUREplatform™ and PUREcoli™ Process & Analytical Development Particle Characterization Core cGMP Manufacturing PH (303) 339-5600 2500 Central Avenue ·…
  • Solid-state & particle characterization
    …e Development leveraging KBI PUREplatform™ and PUREcoli™ Process & Analytical Development Particle Characterization Core cGMP Manufacturing PH (303) 339-5600 2500 Central Avenue · Boulder, CO 80301…

Taken from the part of the company's network/locations page that describes this site. Source: https://www.kbibiopharma.com/about/our-locations, 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. 03 Dec 2021
    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 3011326133, inspection ID 1158021)

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.