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Wuxi Zontai Int'L Corporation Ltd

⚠️ Moderate Risk

FEI: 3003416487 • Wuxi • CHINA

FEI

FEI Number

3003416487

📍

Location

Wuxi

🇨🇳

Country

CHINA
🏢

Address

36 Guang Rui Road, , Wuxi, , China

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
11/29/2010
Latest Refusal
11/29/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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).

Refusal History

DateProductViolationsDivision
11/29/2010
86HPAFRAME, TRIAL, OPHTHALMIC
118NOT LISTED
Cincinnati District Office (CIN-DO)
11/29/2010
86HPCSET, LENS, TRIAL, OPHTHALMIC
118NOT LISTED
Cincinnati District Office (CIN-DO)
11/29/2010
86HRJTABLE, INSTRUMENT, POWERED, OPHTHALMIC
118NOT LISTED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Wuxi Zontai Int'L Corporation Ltd's FDA import refusal history?

Wuxi Zontai Int'L Corporation Ltd (FEI: 3003416487) has 3 FDA import refusal record(s) in our database, spanning from 11/29/2010 to 11/29/2010.

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. Wuxi Zontai Int'L Corporation Ltd's FEI number is 3003416487.

What types of violations has Wuxi Zontai Int'L Corporation Ltd received?

Wuxi Zontai Int'L Corporation Ltd 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 Wuxi Zontai Int'L Corporation Ltd come from?

All FDA import refusal data for Wuxi Zontai Int'L Corporation Ltd 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.