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Facility profile

Sato Pharmaceutical Co., Ltd.

Drug product manufacturing · Packaging & labeling · Tokyo 193-0941 · Japan

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

LabelManufacturePack
Due diligence

Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Official action indicated (OAI)

Nov 21, 2025 · The findings may warrant official FDA action.

Matched compliance actions
Warning Letter · May 2026

Within five years · review the action and follow-up.

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Shows

Registration status and a latest matched official action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Method and source details
View full inspection and compliance history7 inspection records

FDA inspection history

7 records, Nov 2012 – Nov 2025 · 3 NAI · 2 VAI · 2 OAI

DateClassProject areaCitationsFY
Nov 21, 2025OAIDrug Quality AssuranceYes2026
Nov 7, 2019NAIFoodborne Biological Hazards2020
Nov 7, 2019NAIFood Composition, Standards, Labeling and Econ2020
Oct 25, 2019VAIDrug Quality AssuranceYes2020
Jul 3, 2018VAIDrug Quality Assurance2018
Feb 12, 2016OAIDrug Quality AssuranceYes2016
Nov 16, 2012NAIFood Composition, Standards, Labeling and Econ2013

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

May 19, 2026Warning Letter · CDER
Feb 2, 2017Warning Letter · CDER
Unclaimed profile

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