Atlas

FDA-Inspected Site

Rohto Pharmaceutical Co., Ltd.

4 FDA inspections are on record for Rohto Pharmaceutical Co., Ltd. in Iga, Japan.

483· Form 483 issued

Iga, Japan · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-03-08.

At a glance

Inspections

4

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
27 Feb 2023 – 8 Mar 2023Human Drugs483On file
15 Jan 2018 – 2 Mar 2018Human Drugs483View 483 →
10 Nov 2014 – 14 Nov 2014Human Drugs483View 483 →
20 Nov 2012Not recorded483On file

Observations on record

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

2 Mar 2018
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Nadeem I Chaudhry

2 Mar 2018
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Nadeem I Chaudhry

2 Mar 2018
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Nadeem I Chaudhry

14 Nov 2014
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Torrance J Slayton

14 Nov 2014
21 CFR 211.63

Equipment Design, Size and Location

Cited by Torrance J Slayton

Investigators

FDA investigators tied to this site in the record.

Michele Perry-Williams1 insp.
Michael E Maselli1 insp.
Nadeem I Chaudhry1 insp.
Torrance J Slayton1 insp.
Marvin D Jones1 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 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.130(b)Cited across public-safe Form 483 observations1x
21 CFR 211.134(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Rohto Pharmaceutical 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