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Leading Edge

⚠️ Moderate Risk

FEI: 3003482716 • Garden City, CO • UNITED STATES

FEI

FEI Number

3003482716

📍

Location

Garden City, CO

🇺🇸
🏢

Address

2428, , Garden City, CO, United States

Moderate Risk

FDA Import Risk Assessment

46.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
8/19/2004
Latest Refusal
5/2/2002
Earliest Refusal

Score Breakdown

Violation Severity
96.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
13.0×10%
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

2512×

POISONOUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:

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
8/19/2004
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Seattle District Office (SEA-DO)
6/12/2002
54AYY99VITAMIN, N.E.C.
251POISONOUS
New Orleans District Office (NOL-DO)
5/2/2002
54AYY99VITAMIN, N.E.C.
251POISONOUS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Leading Edge's FDA import refusal history?

Leading Edge (FEI: 3003482716) has 3 FDA import refusal record(s) in our database, spanning from 5/2/2002 to 8/19/2004.

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. Leading Edge's FEI number is 3003482716.

What types of violations has Leading Edge received?

Leading Edge has been cited for 2 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 Leading Edge come from?

All FDA import refusal data for Leading Edge 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.