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LEADING EDGE HEALTH

⚠️ Moderate Risk

FEI: 3012691728 • Elizabethton, TN • UNITED STATES

FEI

FEI Number

3012691728

📍

Location

Elizabethton, TN

🇺🇸
🏢

Address

100 Fidelitone Way, , Elizabethton, TN, United States

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
3/15/2019
Latest Refusal
2/22/2019
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

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
3/15/2019
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/15/2019
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/22/2019
54FYY43DAMIANA (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LEADING EDGE HEALTH's FDA import refusal history?

LEADING EDGE HEALTH (FEI: 3012691728) has 3 FDA import refusal record(s) in our database, spanning from 2/22/2019 to 3/15/2019.

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 HEALTH's FEI number is 3012691728.

What types of violations has LEADING EDGE HEALTH received?

LEADING EDGE HEALTH 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 LEADING EDGE HEALTH come from?

All FDA import refusal data for LEADING EDGE HEALTH 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.