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  5. Eli Lilly & Company (NYSE: LLY), Indianapolis, IN – FDA Inspections
Company
•United States•Public company, NYSE: LLY

Eli Lilly & Company (NYSE: LLY), Indianapolis, IN – FDA Inspections

Inspection records and compliance data for Eli Lilly & Company in Indianapolis, Indiana. 36 FDA inspections on record, 5 Form 483s, last inspected January 09, 2026. Publicly traded as NYSE: LLY.

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Company Profile

This profile covers Eli Lilly & Company based in Indianapolis, Indiana, United States.

FDA Inspection History

FDA inspections
36
OAI
0
VAI
12
NAI
21
Unclassified
3
Form 483s
5
Warning letters
0

First inspected September 22, 2009. Last inspected January 9, 2026.

Most cited issue areas

  • Procedures not in writing, fully followed2 inspections
  • Control procedures to monitor and validate performance1 inspection
  • Establish reliability of supplier's C of A1 inspection

FDA inspections (36)

DateResultFDA center(s)Insp. #
January 9, 2026NAIHuman Drugs · Bioresearch Monitoring1298628
May 20, 2025VAIHuman Drugs · Drug Quality Assurance1270621
March 27, 2025Not classifiedHuman Drugs1260339
January 15, 2025NAIHuman Drugs · Bioresearch Monitoring1229895
October 6, 2023Not classifiedHuman Drugs1220489
September 15, 2023VAIHuman Drugs · Bioresearch Monitoring1217806
June 16, 2023Not classifiedHuman Drugs1209522
May 18, 2023NAIMedical Devices & Rad Health · Compliance: Devices1207271
September 30, 2022NAIHuman Drugs · Bioresearch Monitoring1181732
January 13, 2022VAIHuman Drugs · Bioresearch Monitoring1161160
March 16, 2021VAIHuman Drugs · Drug Quality Assurance1137226
March 20, 2020NAIHuman Drugs · Bioresearch Monitoring1122175
January 17, 2020NAIHuman Drugs · Bioresearch Monitoring1116498
March 5, 2019NAIMedical Devices & Rad Health · Compliance: Devices1082843
January 25, 2019NAIHuman Drugs · Bioresearch Monitoring1079503
April 23, 2018VAIHuman Drugs · Bioresearch Monitoring1049177
October 6, 2017NAIMedical Devices & Rad Health · Compliance: Devices1031031
July 28, 2017NAIHuman Drugs · Bioresearch Monitoring1021704
May 25, 2017NAIHuman Drugs · Drug Quality Assurance1017418
July 20, 2016NAIHuman Drugs · Drug Quality Assurance984207
June 10, 2016NAIHuman Drugs · Bioresearch Monitoring981504
May 13, 2016NAIHuman Drugs · Bioresearch Monitoring981583
August 4, 2015NAIHuman Drugs · Drug Quality Assurance937599
May 12, 2015NAIHuman Drugs · Bioresearch Monitoring926741
February 11, 2015NAIHuman Drugs · Bioresearch Monitoring914373
May 8, 2014NAIHuman Drugs · Bioresearch Monitoring877965
December 12, 2013NAIHuman Drugs · Bioresearch Monitoring861847
December 6, 2013VAIMedical Devices & Rad Health · Postmarket Assurance: Devices858117
April 19, 2013VAIHuman Drugs · Drug Quality Assurance831832
February 14, 2013VAIHuman Drugs · Bioresearch Monitoring817823
December 14, 2012VAIHuman Drugs · Bioresearch Monitoring812898
September 29, 2011NAIHuman Drugs · Bioresearch Monitoring747591
August 23, 2011VAIHuman Drugs, Medical Devices & Rad Health · Drug Quality Assurance741024
September 3, 2010VAIHuman Drugs · Bioresearch Monitoring682301
July 28, 2010VAIHuman Drugs · Drug Quality Assurance675885
September 22, 2009NAIHuman Drugs · Drug Quality Assurance613988
FDA documents

Form 483s (10)

  • Form 483s · May 20, 2025
  • Form 483s · October 6, 2023
  • Form 483s · September 15, 2023
  • Form 483s · June 16, 2023
  • Form 483s · October 21, 2022
  • Form 483s · October 17, 2022
  • Form 483s · March 16, 2021
  • Form 483s · March 16, 2021
  • Form 483s · April 23, 2018
  • Form 483s · February 8, 2001

Warning Letters (1)

  • Warning Letters · February 23, 2001

EIRs (4)

  • EIRs · May 18, 2023
  • EIRs · October 21, 2022
  • EIRs · March 20, 2020
  • EIRs · January 17, 2020
People (6)
Rafeeq A. Habeeb
Person
Muna Algharibeh
Person
Qiao Y. Bobo
Person
Wayne E. Seifert
Person
Nicholas F. Lyons
Person
Art O. Czabaniuk
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Amgen, Inc.
Biological E. Limited
Amgen Manufacturing Ltd
FUJIFILM Diosynth Biotechnologies Denmark ApS
Patheon Pharmaceuticals Inc.
Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany
Boehringer Ingelheim Fremont, Inc.
Sumitomo Dainippon Pharma Co., Ltd.
ALK-Abello, Inc.
Advanced Accelerator Applications (Italy) srl
Company Information

Name

Eli Lilly & Company

Stock ticker

LLY

Exchange

NYSE

Share price

$1,430.13

Market cap

$1.3T

Price as of

November 13, 2026

FEI Number

1819470

Address

1 Lilly Corporate Ctr, Indianapolis, Indiana 46285, United States

Country

United States

ID: fc56eed7-d261-4de3-865e-c2aa54162adf

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