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Elite International, Inc.

⚠️ Moderate Risk

FEI: 3004059946 • Songjiang District Shanghai • CHINA

FEI

FEI Number

3004059946

📍

Location

Songjiang District Shanghai

🇨🇳

Country

CHINA
🏢

Address

No. 1370 Donggang Village, Tahui Township, Songjiang District Shanghai, , China

Moderate Risk

FDA Import Risk Assessment

39.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
7/27/2009
Latest Refusal
6/22/2009
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

4774×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

Refusal History

DateProductViolationsDivision
7/27/2009
80FMCGLOVE, PATIENT EXAMINATION
477HOLES
Southwest Import District Office (SWI-DO)
6/22/2009
80FMCGLOVE, PATIENT EXAMINATION
477HOLES
Southwest Import District Office (SWI-DO)
6/22/2009
80FMCGLOVE, PATIENT EXAMINATION
477HOLES
Southwest Import District Office (SWI-DO)
6/22/2009
80FMCGLOVE, PATIENT EXAMINATION
477HOLES
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Elite International, Inc.'s FDA import refusal history?

Elite International, Inc. (FEI: 3004059946) has 4 FDA import refusal record(s) in our database, spanning from 6/22/2009 to 7/27/2009.

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. Elite International, Inc.'s FEI number is 3004059946.

What types of violations has Elite International, Inc. received?

Elite International, 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 Elite International, Inc. come from?

All FDA import refusal data for Elite International, 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.