Atlas

FDA-Inspected Site

Shionogi Pharma Co., Ltd.

7 FDA inspections are on record for Shionogi Pharma Co., Ltd. in Isawa-Gun, Japan.

483· Form 483 issued

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

Overview

  • 7 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-07-01.

At a glance

Inspections

7

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Jun 2025 – 1 Jul 2025Human Drugs483View 483 →
4 Mar 2019 – 15 Mar 2019Human Drugs483On file
20 Sep 2018 – 28 Sep 2018Human DrugsClean
5 Sep 2016 – 16 Sep 2016Human Drugs483On file
24 Mar 2014 – 1 Apr 2014Human Drugs483On file
2 Feb 2012Not recordedClean
10 Aug 2007Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

1 Jul 2025
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Anastasia M Shields, Jessica S Estriplet

1 Jul 2025
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Anastasia M Shields, Jessica S Estriplet

1 Jul 2025
21 CFR 211.42(c)(10)(v)

Cleaning System

Cited by Anastasia M Shields, Jessica S Estriplet

1 Jul 2025
21 CFR 211.42(c)(5)

Mfg / Processing Operations Area

Cited by Anastasia M Shields, Jessica S Estriplet

Investigators

FDA investigators tied to this site in the record.

Anastasia M Shields1 insp.
Jessica S Estriplet1 insp.
Stephanie A Slater1 insp.
Jiao Yang1 insp.
Robert J Martin1 insp.
Barbara J Rincon1 insp.
Michael A Charles1 insp.
Yumi J Hiramine1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(5)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Shionogi Pharma Co., Ltd.'s 4 Form 483s

Source PDFs and recurring CFR citations, 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