ImportRefusal LogoImportRefusal

Lilly del Caribe, Inc.

⚠️ Moderate Risk

FEI: 3004525072 • Carolina, PR • UNITED STATES

FEI

FEI Number

3004525072

📍

Location

Carolina, PR

🇺🇸
🏢

Address

12.3 Km 65th Infantry Road (Pr05), , Carolina, PR, United States

Moderate Risk

FDA Import Risk Assessment

43.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
5/13/2020
Latest Refusal
5/3/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
7.4×10%
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

753×

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
5/13/2020
66SCA51TADALAFIL
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/7/2016
66SCA51TADALAFIL
75UNAPPROVED
Cincinnati District Office (CIN-DO)
5/3/2016
66SCA51TADALAFIL
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Lilly del Caribe, Inc.'s FDA import refusal history?

Lilly del Caribe, Inc. (FEI: 3004525072) has 3 FDA import refusal record(s) in our database, spanning from 5/3/2016 to 5/13/2020.

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. Lilly del Caribe, Inc.'s FEI number is 3004525072.

What types of violations has Lilly del Caribe, Inc. received?

Lilly del Caribe, Inc. 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 Lilly del Caribe, Inc. come from?

All FDA import refusal data for Lilly del Caribe, Inc. 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.