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Wangda Plastic Co Ltd

⚠️ Moderate Risk

FEI: 3009314982 • Kai Feng, Henan • CHINA

FEI

FEI Number

3009314982

📍

Location

Kai Feng, Henan

🇨🇳

Country

CHINA
🏢

Address

# 129 Binhe East Rd, Weishixian, Kai Feng, Henan, China

Moderate Risk

FDA Import Risk Assessment

34.9
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
11/22/2017
Latest Refusal
9/18/2012
Earliest Refusal

Score Breakdown

Violation Severity
66.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
7.7×10%
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.

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
11/22/2017
80LYZGLOVE, PATIENT EXAMINATION, VINYL
3280FRNMFGREG
477HOLES
Division of West Coast Imports (DWCI)
9/18/2012
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Los Angeles District Office (LOS-DO)
9/18/2012
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Los Angeles District Office (LOS-DO)
9/18/2012
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Wangda Plastic Co Ltd's FDA import refusal history?

Wangda Plastic Co Ltd (FEI: 3009314982) has 4 FDA import refusal record(s) in our database, spanning from 9/18/2012 to 11/22/2017.

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. Wangda Plastic Co Ltd's FEI number is 3009314982.

What types of violations has Wangda Plastic Co Ltd received?

Wangda Plastic 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 Wangda Plastic Co Ltd come from?

All FDA import refusal data for Wangda Plastic 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.