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GAOMISHI ZHONGHEXIANG LABOR PROD

⚠️ Moderate Risk

FEI: 3016976008 • Weifang • CHINA

FEI

FEI Number

3016976008

📍

Location

Weifang

🇨🇳

Country

CHINA
🏢

Address

Gaomi Economic Developm, , Weifang, , China

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
8/14/2020
Latest Refusal
8/14/2020
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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).

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

DateProductViolationsDivision
8/14/2020
80NZJRESPIRATOR, N95, HOME USE
118NOT LISTED
223FALSE
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is GAOMISHI ZHONGHEXIANG LABOR PROD's FDA import refusal history?

GAOMISHI ZHONGHEXIANG LABOR PROD (FEI: 3016976008) has 1 FDA import refusal record(s) in our database, spanning from 8/14/2020 to 8/14/2020.

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. GAOMISHI ZHONGHEXIANG LABOR PROD's FEI number is 3016976008.

What types of violations has GAOMISHI ZHONGHEXIANG LABOR PROD received?

GAOMISHI ZHONGHEXIANG LABOR PROD 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 GAOMISHI ZHONGHEXIANG LABOR PROD come from?

All FDA import refusal data for GAOMISHI ZHONGHEXIANG LABOR PROD 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.