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Facility profile

Zydus Lifesciences Limited

Testing & analysis · Drug product manufacturing · Gujarat 382210 · India

FDA recordFDA directory updated Jul 22, 2026Profile not yet claimed3 registered company locations
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.

AnalysisManufacture
Due diligence

Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 22, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Aug 5, 2022 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2019

More than five years old · review later records.

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Shows

Registration status and a latest matched voluntary 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 history10 inspection records

FDA inspection history

10 records, Feb 2009 – Aug 2022 · 4 NAI · 3 VAI · 3 OAI

DateClassProject areaCitationsFY
Aug 5, 2022VAIDrug Quality AssuranceYes2022
May 3, 2019OAIDrug Quality AssuranceYes2019
Mar 22, 2019NAIBioresearch Monitoring2019
Feb 9, 2018NAIDrug Quality Assurance2018
Feb 16, 2017NAIDrug Quality Assurance2017
Sep 5, 2014OAIDrug Quality AssuranceYes2014
Aug 19, 2013VAIDrug Quality Assurance2013
Feb 23, 2012VAIDrug Quality Assurance2012
Feb 3, 2011OAIDrug Quality Assurance2011
Feb 6, 2009NAIDrug Quality Assurance2009

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

Matched compliance actions

Oct 29, 2019Warning Letter · CDER
Dec 23, 2015Warning Letter · CDER
Jun 21, 2011Warning Letter · CDER
Unclaimed profile

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