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Facility profile

Somerset Therapeutics Private Limited

Testing & analysis · Drug product manufacturing · Karnataka 562123 · India

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
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Listed operations

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

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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)

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

Matched compliance actions
Warning Letter · Sep 2025

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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Review the underlying findings, response, and subsequent follow-up before qualification.

Method and source details
View full inspection and compliance history10 inspection records

FDA inspection history

10 records, Mar 2009 – Feb 2025 · 1 NAI · 5 VAI · 4 OAI

DateClassProject areaCitationsFY
Feb 21, 2025OAIDrug Quality Assurance2025
Oct 27, 2023VAIDrug Quality Assurance2024
Apr 4, 2022OAIDrug Quality AssuranceYes2022
Feb 19, 2020OAIDrug Quality Assurance2020
Jul 23, 2019VAIDrug Quality AssuranceYes2019
Dec 5, 2017VAIDrug Quality Assurance2018
Apr 24, 2017NAIDrug Quality Assurance2017
Aug 20, 2013VAIDrug Quality AssuranceYes2013
Sep 20, 2011OAIDrug Quality Assurance2011
Mar 31, 2009VAIDrug Quality Assurance2009

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

Matched compliance actions

Sep 4, 2025Warning Letter · CDER
Aug 13, 2020Warning Letter · CDER
Feb 23, 2012Warning Letter · CDER
Unclaimed profile

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