by ComplianceQuest

My Dashboard Inspection Tracker FDA Guidance Templates Assessments

Sign in Get started

Tracker Overview Enforcement Themes Form 483s Warning Letters Inspections Recalls Investigators Companies Facilities

ANALYTICS

Tracker Overview Enforcement Themes

FDA ACTIONS

Form 483s Warning Letters Inspections Recalls

AUDIT READINESS

COMPANIES

Companies Facilities

Loading…

Dashboard Warning LettersWarning Letter Details

Rohto Pharmaceutical Co., Ltd. Warning Letter Details

Warning Letter

Rohto Pharmaceutical Co., Ltd.

Recipient Title Chairman and Representative Director, Rohto Pharmaceutical Co., Ltd., 1-8-1 Tatsuminishi Ikuno-Ku , Osaka 544-8666 Japan, (b)(4)

Issue DateOctober 14, 2026

FEI Number3008808745

Violations5

CountryJapan

Issuing Office

Center for Drug Evaluation and Research (CDER)

Product Type

Drugs

Status

Open

Subject

CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

Rohto Pharmaceutical Co., Ltd. FDA Warning Letter, October 14, 2026