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Zhaoqing Winly Foreign Trade Develo

✅ Low Risk

FEI: 3004698324 • Guangdong • CHINA

FEI

FEI Number

3004698324

📍

Location

Guangdong

🇨🇳

Country

CHINA
🏢

Address

No.18, Jiangbin Xi Road, Zhaoqing, , Guangdong, , China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
2/3/2011
Latest Refusal
2/3/2011
Earliest Refusal

Score Breakdown

Violation Severity
42.5×40%
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

1182×

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).

30001×

N-RX INACT

The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
2/3/2011
66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
3000N-RX INACT
472NO ENGLISH
New York District Office (NYK-DO)
2/3/2011
66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Zhaoqing Winly Foreign Trade Develo's FDA import refusal history?

Zhaoqing Winly Foreign Trade Develo (FEI: 3004698324) has 2 FDA import refusal record(s) in our database, spanning from 2/3/2011 to 2/3/2011.

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. Zhaoqing Winly Foreign Trade Develo's FEI number is 3004698324.

What types of violations has Zhaoqing Winly Foreign Trade Develo received?

Zhaoqing Winly Foreign Trade Develo has been cited for 3 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 Zhaoqing Winly Foreign Trade Develo come from?

All FDA import refusal data for Zhaoqing Winly Foreign Trade Develo 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.