ImportRefusal LogoImportRefusal

TOM FORD FENDI LV

⚠️ Moderate Risk

FEI: 3027400215 • Port Washington, NY • UNITED STATES

FEI

FEI Number

3027400215

📍

Location

Port Washington, NY

🇺🇸
🏢

Address

12 Harbor Park Dr, , Port Washington, NY, United States

Moderate Risk

FDA Import Risk Assessment

34.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
7/21/2023
Latest Refusal
7/21/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
49.9×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
7/21/2023
86HOISPECTACLE, MAGNIFYING
118NOT LISTED
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is TOM FORD FENDI LV's FDA import refusal history?

TOM FORD FENDI LV (FEI: 3027400215) has 1 FDA import refusal record(s) in our database, spanning from 7/21/2023 to 7/21/2023.

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. TOM FORD FENDI LV's FEI number is 3027400215.

What types of violations has TOM FORD FENDI LV received?

TOM FORD FENDI LV 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 TOM FORD FENDI LV come from?

All FDA import refusal data for TOM FORD FENDI LV 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.