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Facility profile

ONESOURCE SPECIALTY PHARMA LIMITED

Testing & analysis · Drug product manufacturing · Karnataka 560076 · India

FDA recordFDA directory updated Jul 21, 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.

AnalysisLabelManufacturePackSterilize
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
Voluntary action indicated (VAI)

Mar 28, 2024 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2015

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 history8 inspection records

FDA inspection history

8 records, Mar 2009 – Mar 2024 · 1 NAI · 6 VAI · 1 OAI

DateClassProject areaCitationsFY
Mar 28, 2024VAIDrug Quality AssuranceYes2024
Dec 20, 2019VAIDrug Quality AssuranceYes2020
Mar 13, 2018VAIDrug Quality AssuranceYes2018
Mar 16, 2016VAIDrug Quality Assurance2016
Aug 8, 2014OAIDrug Quality Assurance2014
Aug 12, 2013VAIDrug Quality Assurance2013
Sep 29, 2011VAIDrug Quality AssuranceYes2011
Mar 17, 2009NAIDrug Quality Assurance2009

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

Matched compliance actions

Aug 7, 2015Warning Letter · CDER
Unclaimed profile

Service details not yet provided

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

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