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Facility profile

Shionogi Pharma Co., Ltd.

Testing & analysis · Drug product manufacturing · Iwate 029-4503 · 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.

AnalysisActive pharmaceutical ingredient (API) manufactureLabelManufacturePack
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)

Jul 1, 2025 · The findings may warrant official FDA action.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

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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, Jul 2010 – Jul 2025 · 3 NAI · 3 VAI · 1 OAI

DateClassProject areaCitationsFY
Jul 1, 2025OAIDrug Quality AssuranceYes2025
Sep 28, 2018NAIDrug Quality Assurance2018
Sep 16, 2016NAIDrug Quality Assurance2016
Sep 16, 2016VAIDrug Quality Assurance2016
Apr 1, 2014VAIDrug Quality Assurance2014
Feb 2, 2012NAIDrug Quality Assurance2012
Jul 26, 2010VAIDrug Quality Assurance2010

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

Matched compliance actions

No warning letter, injunction, or seizure is matched in the current data set.

Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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