ImportRefusal LogoImportRefusal

The Winning Combination Usa Inc

⚠️ Moderate Risk

FEI: 3006576271 • Charlotte, NC • UNITED STATES

FEI

FEI Number

3006576271

📍

Location

Charlotte, NC

🇺🇸
🏢

Address

14012 Dovehunt Pl, , Charlotte, NC, United States

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/30/2008
Latest Refusal
10/30/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

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
10/30/2008
66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is The Winning Combination Usa Inc's FDA import refusal history?

The Winning Combination Usa Inc (FEI: 3006576271) has 1 FDA import refusal record(s) in our database, spanning from 10/30/2008 to 10/30/2008.

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. The Winning Combination Usa Inc's FEI number is 3006576271.

What types of violations has The Winning Combination Usa Inc received?

The Winning Combination Usa 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 The Winning Combination Usa Inc come from?

All FDA import refusal data for The Winning Combination Usa 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.