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Eastever International Trading Co.

⚠️ Moderate Risk

FEI: 3003671352 • Shenzhen • HONG KONG

FEI

FEI Number

3003671352

📍

Location

Shenzhen

🇭🇰

Country

HONG KONG
🏢

Address

Room A4-Ad, 18/F Block A, , Shenzhen, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
6/2/2003
Latest Refusal
10/16/2002
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

4791×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

DateProductViolationsDivision
6/2/2003
80FLKTHERMOMETER, CLINICAL MERCURY
479DV QUALITY
San Juan District Office (SJN-DO)
10/16/2002
78FCNKIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER
341REGISTERED
San Juan District Office (SJN-DO)

Frequently Asked Questions

What is Eastever International Trading Co.'s FDA import refusal history?

Eastever International Trading Co. (FEI: 3003671352) has 2 FDA import refusal record(s) in our database, spanning from 10/16/2002 to 6/2/2003.

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. Eastever International Trading Co.'s FEI number is 3003671352.

What types of violations has Eastever International Trading Co. received?

Eastever International Trading Co. 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 Eastever International Trading Co. come from?

All FDA import refusal data for Eastever International Trading Co. 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.