FDA-Inspected Site

TOYO Pharmaceutical Co., Ltd.

2 FDA inspections are on record for TOYO Pharmaceutical Co., Ltd. in Osaka, Japan.

483· Form 483 issued

Osaka, Japan · Last updated August 15, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-12.

At a glance

Inspections

2

Form 483s

2

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Jun 2026 – 12 Jun 2026Human Drugs483View 483 →
12 Jun 2023 – 16 Jun 2023Human Drugs483View 483 →

Observations on record

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

12 Jun 2026
21 CFR 211.170(b)

Annual visual exams of drug products

Cited by Wayne D Mcgrath

12 Jun 2026
21 CFR 211.170(b)

Drug product reserve containers

Cited by Wayne D Mcgrath

12 Jun 2026
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Wayne D Mcgrath

12 Jun 2026
21 CFR 211.68(b)

Computer control of master formula records

Cited by Wayne D Mcgrath

16 Jun 2023
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by Christopher R Czajka

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.170(b)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind TOYO Pharmaceutical Co., Ltd.'s 2 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