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Btg Usa Prodigy Trading Import

⚠️ Moderate Risk

FEI: 3011464782 • Shenzhen • CHINA

FEI

FEI Number

3011464782

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

215 LI Xin Nan Road Huai de Fuyong Bao, , Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/15/2015
Latest Refusal
5/15/2015
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

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
5/15/2015
79OHVFOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION
16DIRECTIONS
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Btg Usa Prodigy Trading Import's FDA import refusal history?

Btg Usa Prodigy Trading Import (FEI: 3011464782) has 1 FDA import refusal record(s) in our database, spanning from 5/15/2015 to 5/15/2015.

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. Btg Usa Prodigy Trading Import's FEI number is 3011464782.

What types of violations has Btg Usa Prodigy Trading Import received?

Btg Usa Prodigy Trading Import 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 Btg Usa Prodigy Trading Import come from?

All FDA import refusal data for Btg Usa Prodigy Trading Import 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.