FDA-Inspected Site

Unigen Inc.

3 FDA inspections are on record for Unigen Inc. in Ibi-Gun, Japan.

483· Form 483 issued

Ibi-Gun, Japan · Last updated July 10, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-03-10.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Mar 2023 – 10 Mar 2023Biologics483On file
2 Mar 2023 – 9 Mar 2023Biologics483On file
12 Jun 2017 – 15 Jun 2017Biologics483On file

Investigators

FDA investigators tied to this site in the record.

Full site report

Get the verbatim findings behind Unigen Inc.'s 3 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