Atlas

FDA-Inspected Site

FujiFilm Diosynth Biotechnologies U.S.A., Inc.

15 FDA inspections are on record for FujiFilm Diosynth Biotechnologies U.S.A., Inc. in Research Triangle Park, United States.

483· Form 483 issued

Research Triangle Park, United States · Last updated July 10, 2026

Overview

  • 15 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-27.

At a glance

Inspections

15

Form 483s

8

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Mar 2026 – 27 Mar 2026Human Drugs483On file
6 Feb 2023 – 10 Feb 2023Human Drugs483On file
14 Apr 2021 – 21 Apr 2021Human Drugs483On file
25 Feb 2019 – 1 Mar 2019Human Drugs483On file
18 Feb 2019 – 22 Feb 2019Human Drugs483On file
22 Oct 2018 – 26 Oct 2018Human Drugs483On file
5 Feb 2018 – 9 Feb 2018Human DrugsClean
24 Mar 2016 – 31 Mar 2016Human DrugsClean
27 Apr 2015 – 1 May 2015Human Drugs483On file
10 Sep 2013 – 12 Sep 2013Human DrugsClean
16 Jul 2010Not recordedClean
11 Sep 2008Not recorded483On file

Investigators

FDA investigators tied to this site in the record.

Veronica Fuentes3 insp.
Amy A Devlin3 insp.
Seneca D Toms2 insp.
Thuy T Nguyen2 insp.
Penny H Mccarver2 insp.
Saundrea A Munroe1 insp.
Kayla V Sprague1 insp.
Jee Y Chung1 insp.
Yuan-Chia Kuo1 insp.
Charles Y Kuo1 insp.
Zhihao Pete Qiu1 insp.
Jacek Cieslak1 insp.
Yun Wu1 insp.
Steven Fong1 insp.
V Ashutosh Rao1 insp.
Sonya M Edmonds1 insp.
Bonita S Chester1 insp.
Bo Chi1 insp.
Jason F Chancey1 insp.

Full site report

Get the verbatim findings behind FujiFilm Diosynth Biotechnologies U.S.A., Inc.'s 8 Form 483s

The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat