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Heng Fung Plastic Toys Factory

✅ Low Risk

FEI: 1000418137 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

1000418137

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Heng Fung Bldg, Heng Gang District, Liu Yue, Bao An County, Shenzhen, Guangdong, China

Low Risk

FDA Import Risk Assessment

23.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
12/16/2002
Latest Refusal
12/16/2002
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1181×

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).

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
12/16/2002
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Heng Fung Plastic Toys Factory's FDA import refusal history?

Heng Fung Plastic Toys Factory (FEI: 1000418137) has 1 FDA import refusal record(s) in our database, spanning from 12/16/2002 to 12/16/2002.

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. Heng Fung Plastic Toys Factory's FEI number is 1000418137.

What types of violations has Heng Fung Plastic Toys Factory received?

Heng Fung Plastic Toys Factory 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 Heng Fung Plastic Toys Factory come from?

All FDA import refusal data for Heng Fung Plastic Toys Factory 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.