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Wywye Industrial Co Ltd

⚠️ Moderate Risk

FEI: 3007635885 • Shenzhenshenzhen • CHINA

FEI

FEI Number

3007635885

📍

Location

Shenzhenshenzhen

🇨🇳

Country

CHINA
🏢

Address

No.608a, 418 Block, Sangda Industrial, , Shenzhenshenzhen, , China

Moderate Risk

FDA Import Risk Assessment

41.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
8/20/2009
Latest Refusal
8/20/2009
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1185×

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).

755×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
8/20/2009
66BAL44NICOTINE DELIVERY SYSTEM
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
8/20/2009
66BAS44NICOTINE DELIVERY SYSTEM
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
8/20/2009
80MSNCIGARETTES (CONTAINING TOBACCO)
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
8/20/2009
66BAS44NICOTINE DELIVERY SYSTEM
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
8/20/2009
66BAS44NICOTINE DELIVERY SYSTEM
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Wywye Industrial Co Ltd's FDA import refusal history?

Wywye Industrial Co Ltd (FEI: 3007635885) has 5 FDA import refusal record(s) in our database, spanning from 8/20/2009 to 8/20/2009.

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. Wywye Industrial Co Ltd's FEI number is 3007635885.

What types of violations has Wywye Industrial Co Ltd received?

Wywye Industrial Co Ltd 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 Wywye Industrial Co Ltd come from?

All FDA import refusal data for Wywye Industrial Co 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.