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Facility profile

Eli Lilly and Company

Testing & analysis · Drug product manufacturing · Indianapolis, IN

FDA recordFDA directory updated Jul 22, 2026Profile not yet claimed10 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.

AnalysisActive pharmaceutical ingredient (API) manufactureLabelManufacturePack
Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 22, 2026

Latest matched inspection
No action indicated (NAI)

Jan 9, 2026 · No conditions warranted FDA action in this inspection.

Matched compliance actions
Warning Letter · Sep 2025

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

Understand this record

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Shows

Registration status and a latest matched no action indicated inspection.

Doesn’t show

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

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Confirm the inspection scope and whether it covered the work you need.

Method and source details
View full inspection and compliance history41 inspection records

FDA inspection history

41 records, Sep 2009 – Jan 2026 · 24 NAI · 17 VAI · 0 OAI

DateClassProject areaCitationsFY
Jan 9, 2026NAIBioresearch Monitoring2026
May 20, 2025VAIDrug Quality Assurance2025
Mar 27, 2025VAIBioresearch Monitoring2025
Jan 15, 2025NAIBioresearch Monitoring2025
Sep 15, 2023VAIBioresearch MonitoringYes2023
May 18, 2023NAICompliance: Devices2023
Sep 30, 2022NAIBioresearch Monitoring2022
Jan 13, 2022VAIBioresearch Monitoring2022
Mar 16, 2021VAIDrug Quality Assurance2021
Mar 20, 2020NAIBioresearch Monitoring2020
Jan 17, 2020NAIBioresearch Monitoring2020
Mar 5, 2019NAICompliance: Devices2019
Jan 25, 2019NAIBioresearch Monitoring2019
Apr 23, 2018VAIBioresearch MonitoringYes2018
Apr 23, 2018VAIBioresearch MonitoringYes2018
Oct 6, 2017NAICompliance: Devices2018
Oct 6, 2017NAIPostmarket Assurance: Devices2018
Jul 28, 2017NAIBioresearch Monitoring2017
May 25, 2017NAIDrug Quality Assurance2017
Jul 20, 2016NAIBioresearch Monitoring2016
Jul 20, 2016NAIDrug Quality Assurance2016
Jun 10, 2016NAIBioresearch Monitoring2016
May 13, 2016NAIBioresearch Monitoring2016
Aug 4, 2015NAIDrug Quality Assurance2015
May 12, 2015NAIBioresearch Monitoring2015
Feb 11, 2015NAIBioresearch Monitoring2015
Feb 11, 2015NAIBioresearch Monitoring2015
May 8, 2014NAIBioresearch Monitoring2014
Dec 12, 2013NAIBioresearch Monitoring2014
Dec 6, 2013VAIPostmarket Assurance: Devices2014
Dec 6, 2013VAICompliance: Devices2014
Apr 19, 2013VAIDrug Quality Assurance2013
Feb 14, 2013VAIBioresearch Monitoring2013
Dec 14, 2012VAIBioresearch Monitoring2013
Sep 29, 2011NAIBioresearch Monitoring2011
Aug 23, 2011VAICompliance: Devices2011
Aug 23, 2011VAIDrug Quality Assurance2011
Sep 3, 2010VAIBioresearch MonitoringYes2010
Sep 3, 2010VAIBioresearch MonitoringYes2010
Jul 28, 2010VAIDrug Quality AssuranceYes2010
Sep 22, 2009NAIDrug Quality Assurance2009

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

Matched compliance actions

Sep 9, 2025Warning Letter · CDER
Sep 9, 2025Warning Letter · CDER
Sep 9, 2025Warning 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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