Atlas

FDA-Inspected Site

TEIKOKU SEIYAKU CO.,LTD.

6 FDA inspections are on record for TEIKOKU SEIYAKU CO.,LTD. in Higashikagawa, Japan.

Clean· No action indicated

Higashikagawa, Japan · Last updated July 10, 2026

Overview

  • 6 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-02-14.

At a glance

Inspections

6

Form 483s

4

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
10 Feb 2025 – 14 Feb 2025Human DrugsClean
2 Jul 2018 – 6 Jul 2018Human Drugs483View 483 →
5 Sep 2016 – 9 Sep 2016Human Drugs483On file
10 Mar 2014 – 14 Mar 2014Human Drugs483View 483 →
26 Mar 2009Not recorded483On file
22 Aug 2001Not recordedClean

Observations on record

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

6 Jul 2018
21 CFR 211.165(a)

Testing and release for distribution

Cited by Satheesh Thomas

14 Mar 2014
21 CFR 211.84(b)

Representative Samples

Cited by Vlada Matusovsky, Sina Shojaee

14 Mar 2014
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Vlada Matusovsky, Sina Shojaee

14 Mar 2014
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Vlada Matusovsky, Sina Shojaee

14 Mar 2014
21 CFR 211.180(b)

Record maintenance 1 year (except exempt OTC)

Cited by Vlada Matusovsky, Sina Shojaee

Investigators

FDA investigators tied to this site in the record.

Matthew B Casale1 insp.
Satheesh Thomas1 insp.
Lindsey M Schwierjohann1 insp.
Vlada Matusovsky1 insp.
Sina Shojaee1 insp.
Jose R Hernandez1 insp.
Javier O Vega1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(b)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.84(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind TEIKOKU SEIYAKU CO.,LTD.'s 4 Form 483s

Source PDFs, verbatim observations, 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