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TANGSHAN LINYANG TRADE

⚠️ Moderate Risk

FEI: 3014054186 • Hebei • CHINA

FEI

FEI Number

3014054186

📍

Location

Hebei

🇨🇳

Country

CHINA
🏢

Address

Dongbashangzhulou 3-2-6, , Hebei, , 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
4/30/2018
Latest Refusal
4/30/2018
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).

2311×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

Refusal History

DateProductViolationsDivision
4/30/2018
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
231LENS CERT
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is TANGSHAN LINYANG TRADE's FDA import refusal history?

TANGSHAN LINYANG TRADE (FEI: 3014054186) has 1 FDA import refusal record(s) in our database, spanning from 4/30/2018 to 4/30/2018.

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. TANGSHAN LINYANG TRADE's FEI number is 3014054186.

What types of violations has TANGSHAN LINYANG TRADE received?

TANGSHAN LINYANG TRADE 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 TANGSHAN LINYANG TRADE come from?

All FDA import refusal data for TANGSHAN LINYANG TRADE 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.