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Eli Lilly And Company Limited

⚠️ Moderate Risk

FEI: 1000656034 • Basingstoke, Hants • UNITED KINGDOM

FEI

FEI Number

1000656034

📍

Location

Basingstoke, Hants

🇬🇧
🏢

Address

Kingsclere Road, , Basingstoke, Hants, United Kingdom

Moderate Risk

FDA Import Risk Assessment

39.6
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

5
Total Refusals
3
Unique Violations
10/11/2013
Latest Refusal
4/7/2004
Earliest Refusal

Score Breakdown

Violation Severity
76.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
5.3×10%
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

1792×

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.

752×

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).

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
10/11/2013
60WOP99ANTHELMINTIC, N.E.C.
72NEW VET DR
Cincinnati District Office (CIN-DO)
9/19/2008
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/24/2005
61NCP99ANTI-DEPRESSANT N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
4/11/2004
65PDB02SILDENAFIL CITRATE (REGULATOR)
179AGR RX
New Orleans District Office (NOL-DO)
4/7/2004
66NCA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II
179AGR RX
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Eli Lilly And Company Limited's FDA import refusal history?

Eli Lilly And Company Limited (FEI: 1000656034) has 5 FDA import refusal record(s) in our database, spanning from 4/7/2004 to 10/11/2013.

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 And Company Limited's FEI number is 1000656034.

What types of violations has Eli Lilly And Company Limited received?

Eli Lilly And Company Limited has been cited for 3 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 And Company Limited come from?

All FDA import refusal data for Eli Lilly And Company Limited 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.