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KBI Biopharma — Durham

Durham, North Carolina, 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)
3004638264 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Durham, North Carolina, United States 27704
Records matched
5 FDA inspections
Most recent FDA inspection in dataset
01 Apr 2026 — VAI

Capabilities (from the company's website)

  • Biologics drug substance
    …Durham, NC 27703 Hamlin Road Durham, NC Mammalian Clinical & Commercial cGMP Manufacturing Analytical, Formulation, Stability QC Mass Spect…

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. 01 Apr 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 3004638264, inspection ID 1312108)

  2. 11 Apr 2018
    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 3004638264, inspection ID 1051652)

  3. 16 Jul 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 3004638264, inspection ID 937768)

  4. 29 Aug 2012
    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 3004638264, inspection ID 796226)

  5. 09 Oct 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 3004638264, inspection ID 625271)

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.