Eli Lilly & Company
🚨 Critical Risk
FEI: 1819470 • Indianapolis, IN • UNITED STATES
FEI Number
1819470
Location
Indianapolis, IN
Country
UNITED STATESAddress
1 Lilly Corporate Ctr, , Indianapolis, IN, United States
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
AGRINSULIN
The article appears to be composed wholly or partly of insulin manufactured in the US and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for a medical emergency
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2025 | 61PCK74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2025 | 58HCP99ENDOCRINE-METABOLIC AGENT, NEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP99ENDOCRINE-METABOLIC AGENT, NEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP09INSULIN GLARGINE | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP09INSULIN GLARGINE | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP99ENDOCRINE-METABOLIC AGENT, NEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP99ENDOCRINE-METABOLIC AGENT, NEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP09INSULIN GLARGINE | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP09INSULIN GLARGINE | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 58HCP09INSULIN GLARGINE | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/4/2025 | 61PCP54LISPRO INSULIN (ANTI-DIABETIC) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/3/2025 | 58MCP11IXEKIZUMAB | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/3/2025 | 58MCP11IXEKIZUMAB | 179AGR RX | Division of West Coast Imports (DWCI) |
| 10/23/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2025 | 62QCE05BARICITINIB (ANTI-RHEUMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/27/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/3/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2025 | 61PDY73EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/6/2025 | 61PCK74TIRZEPATIDE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 5/12/2025 | 61PDY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2025 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/27/2024 | 61PCL74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/18/2024 | 61PCY74TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/5/2024 | 61NCA29FLUOXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2021 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2020 | 61PCB99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/10/2019 | 61PDY35INSULIN HUMAN/INSULIN SUSP ISOPHANE HUMA (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 61PCP17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/11/2017 | 61PCK17INSULIN (INJ) (ANTI-DIABETIC) | 2060AGRINSULIN | New Orleans District Office (NOL-DO) |
| 10/18/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/20/2016 | 66SCB51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/20/2016 | 66SCB51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/3/2015 | 66NCA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 179AGR RX | Florida District Office (FLA-DO) |
| 6/2/2015 | 66SCC51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/20/2013 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 2060AGRINSULIN | Cincinnati District Office (CIN-DO) |
| 6/15/2012 | 66NCA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/6/2012 | 61PDK58INSULIN LISPRO PROTAMINE (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 9/30/2011 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 9/30/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 9/30/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 9/30/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 9/30/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 9/30/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 9/30/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 9/9/2011 | 66SCA51TADALAFIL | 179AGR RX | New Orleans District Office (NOL-DO) |
| 3/22/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/22/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/22/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/22/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/16/2011 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/16/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/16/2011 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/16/2011 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/16/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/16/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/16/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/14/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/14/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 1/4/2011 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 1/4/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 1/4/2011 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 1/4/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 1/4/2011 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 1/4/2011 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 1/4/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 1/4/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 9/22/2010 | 61PCK17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/31/2007 | 61PIY17INSULIN (INJ) (ANTI-DIABETIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/31/2006 | 66SCA51TADALAFIL | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Eli Lilly & Company's FDA import refusal history?
Eli Lilly & Company (FEI: 1819470) has 69 FDA import refusal record(s) in our database, spanning from 10/31/2006 to 11/20/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Eli Lilly & Company's FEI number is 1819470.
What types of violations has Eli Lilly & Company received?
Eli Lilly & Company has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Eli Lilly & Company come from?
All FDA import refusal data for Eli Lilly & Company is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.