Atlas

FDA-Inspected Site

AGC Biologics, Inc.

14 FDA inspections are on record for AGC Biologics, Inc. in Bothell, United States.

483· Form 483 issued

Bothell, United States · Last updated July 9, 2026

Overview

  • 14 FDA inspections are on record.
  • 9 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-04-18.

At a glance

Inspections

14

Form 483s

9

EIRs

7

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
14 Apr 2025 – 18 Apr 2025Biologics483On file
20 Mar 2024 – 27 Mar 2024Human Drugs483On file
2 Feb 2023 – 10 Feb 2023Human Drugs483On file
12 Jul 2021 – 23 Jul 2021Biologics483On file
12 Jul 2021 – 22 Jul 2021BiologicsClean
11 Mar 2021 – 19 Mar 2021Human Drugs483On file
27 Oct 2020 – 2 Nov 2020Human Drugs483On file
12 Apr 2017 – 20 Apr 2017Biologics483On file
18 Apr 2016 – 22 Apr 2016Biologics483On file
28 Mar 2016BiologicsClean
5 May 2015 – 15 May 2015Human DrugsClean
1 Jun 2014 – 6 Jun 2014Biologics483On file

Investigators

FDA investigators tied to this site in the record.

Prabhu P Raju3 insp.
Donald B Ertel2 insp.
Joan Johnson2 insp.
Vanessa Y Jacobs2 insp.
Scott T Ballard1 insp.
Christian Lynch1 insp.
Michael Shanks1 insp.
Jeanne M Fringer1 insp.
Jiangsong Jiang1 insp.
Andrew K Haack1 insp.
Zhong Li1 insp.
Michael Araneta1 insp.
Yuan-Chia Kuo1 insp.
Charles Y Kuo1 insp.
Wayne E Seifert1 insp.
Christopher R Czajka1 insp.
Richard Ledwidge1 insp.
Kathryn E King1 insp.
Anita Narula1 insp.
Mihaly S Ligmond1 insp.
Deborah M Trout1 insp.
Rabia Ballica1 insp.
Barbara J Breithaupt1 insp.
S. L Brown1 insp.

Full site report

Get the verbatim findings behind AGC Biologics, Inc.'s 9 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