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FUJIFILM Biotechnologies — Research Triangle Park

Research Triangle Park, North Carolina, United States · CDMO

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

Site facts

Company
FUJIFILM Biotechnologies
Name(s) in FDA data
FujiFilm Diosynth Biotechnologies U.S.A., Inc.
FEI number(s)
3000718852 (present in FDA Data Dashboard records for this name and city)
Location (as in FDA data)
Research Triangle Park, North Carolina, United States 27709
Records matched
5 FDA inspections
Most recent FDA inspection in dataset
21 Apr 2021 — VAI

Capabilities (from the company's website)

  • Biologics drug substance
    …y operating as a non-sterile, bioburden-controlled, API multi-product facility performing cell culture, purification, and bulk fill. The site is also home to our Bioprocess Innovation Center a…
  • API / drug substance (chemical)
    …a cGMP compliant manufacturing facility operating as a non-sterile, bioburden-controlled, API multi-product facility performing cell culture, purification, and bulk fill. The site is…
  • Microbiology
    …rk (RTP), NC, we have a cGMP compliant manufacturing facility operating as a non-sterile, bioburden-controlled, API multi-product facility performing cell culture, purification, and bulk fi…

Taken from the company's web page for this site. Source: https://fujifilmbiotechnologies.fujifilm.com/cdmo-facilities/usa/research-triangle-park/, 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. 21 Apr 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 3000718852, inspection ID 1140593)

  2. 09 Feb 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 3000718852, inspection ID 1045267)

  3. 31 Mar 2016
    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 3000718852, inspection ID 989406)

  4. 12 Sep 2013
    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 3000718852, inspection ID 848000)

  5. 16 Jul 2010
    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 3000718852, inspection ID 679053)

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.