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ELI LILLY AND COMPANY LTD

⚠️ High Risk

FEI: 3020889412 • Bracknell, Berkshire • UNITED KINGDOM

FEI

FEI Number

3020889412

📍

Location

Bracknell, Berkshire

🇬🇧
🏢

Address

8 Arlington Square West, , Bracknell, Berkshire, United Kingdom

High Risk

FDA Import Risk Assessment

53.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
12/27/2024
Latest Refusal
12/27/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
63.6×20%
Frequency
10.0×10%
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

751×

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).

Refusal History

DateProductViolationsDivision
12/27/2024
61PCY74TIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ELI LILLY AND COMPANY LTD's FDA import refusal history?

ELI LILLY AND COMPANY LTD (FEI: 3020889412) has 1 FDA import refusal record(s) in our database, spanning from 12/27/2024 to 12/27/2024.

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 LTD's FEI number is 3020889412.

What types of violations has ELI LILLY AND COMPANY LTD received?

ELI LILLY AND COMPANY LTD has been cited for 1 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 LTD come from?

All FDA import refusal data for ELI LILLY AND COMPANY LTD 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.