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TREE GROUP., LIMITED

✅ Low Risk

FEI: 3011533853 • Kowloon Bay, Kowloon • HONG KONG

FEI

FEI Number

3011533853

📍

Location

Kowloon Bay, Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

8/F, Office 5 Mega Cube; 8 Wang Kwong Road, Kowloon Bay, Kowloon, Hong Kong

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
9/8/2017
Latest Refusal
9/8/2017
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

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).

2881×

STD LABEL

The article appears to not bear labeling prescribed by the performance standard established under section 514.

Refusal History

DateProductViolationsDivision
9/8/2017
76EAPUNIT, X-RAY, INTRAORAL
118NOT LISTED
288STD LABEL
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is TREE GROUP., LIMITED's FDA import refusal history?

TREE GROUP., LIMITED (FEI: 3011533853) has 1 FDA import refusal record(s) in our database, spanning from 9/8/2017 to 9/8/2017.

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. TREE GROUP., LIMITED's FEI number is 3011533853.

What types of violations has TREE GROUP., LIMITED received?

TREE GROUP., LIMITED 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 TREE GROUP., LIMITED come from?

All FDA import refusal data for TREE GROUP., LIMITED 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.