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Hebei Huang Hua Foreign Trade/Econ Corp

✅ Low Risk

FEI: 3004120717 • Huang Hua City • CHINA

FEI

FEI Number

3004120717

📍

Location

Huang Hua City

🇨🇳

Country

CHINA
🏢

Address

8 Wen Hua Rd, , Huang Hua City, , China

Low Risk

FDA Import Risk Assessment

23.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
8/31/2011
Latest Refusal
8/31/2011
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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).

3412×

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
8/31/2011
76EBHMATERIAL, IMPRESSION TRAY, RESIN
118NOT LISTED
341REGISTERED
New York District Office (NYK-DO)
8/31/2011
76JEWTIP, RUBBER, ORAL HYGIENE
118NOT LISTED
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Hebei Huang Hua Foreign Trade/Econ Corp's FDA import refusal history?

Hebei Huang Hua Foreign Trade/Econ Corp (FEI: 3004120717) has 2 FDA import refusal record(s) in our database, spanning from 8/31/2011 to 8/31/2011.

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. Hebei Huang Hua Foreign Trade/Econ Corp's FEI number is 3004120717.

What types of violations has Hebei Huang Hua Foreign Trade/Econ Corp received?

Hebei Huang Hua Foreign Trade/Econ Corp 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 Hebei Huang Hua Foreign Trade/Econ Corp come from?

All FDA import refusal data for Hebei Huang Hua Foreign Trade/Econ Corp 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.