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Lipozene

⚠️ Moderate Risk

FEI: 3005889017 • Reno, NV • UNITED STATES

FEI

FEI Number

3005889017

📍

Location

Reno, NV

🇺🇸
🏢

Address

4910 Longley Ln Ste 101, , Reno, NV, United States

Moderate Risk

FDA Import Risk Assessment

40.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
2/24/2014
Latest Refusal
12/10/2013
Earliest Refusal

Score Breakdown

Violation Severity
83.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
2/24/2014
54FYA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Seattle District Office (SEA-DO)
12/10/2013
66VBE99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Lipozene's FDA import refusal history?

Lipozene (FEI: 3005889017) has 2 FDA import refusal record(s) in our database, spanning from 12/10/2013 to 2/24/2014.

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. Lipozene's FEI number is 3005889017.

What types of violations has Lipozene received?

Lipozene 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 Lipozene come from?

All FDA import refusal data for Lipozene 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.