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RUI AN JIA QI POLARIZER CO., LTD

⚠️ Moderate Risk

FEI: 3010374980 • Wenzhou, Zhejiang • CHINA

FEI

FEI Number

3010374980

📍

Location

Wenzhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Dongshan Economic, Development Zone Ruian, Wenzhou, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
8/2/2017
Latest Refusal
6/12/2017
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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).

Refusal History

DateProductViolationsDivision
8/2/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
Division of Southeast Imports (DSEI)
6/13/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
Division of Southeast Imports (DSEI)
6/12/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is RUI AN JIA QI POLARIZER CO., LTD's FDA import refusal history?

RUI AN JIA QI POLARIZER CO., LTD (FEI: 3010374980) has 3 FDA import refusal record(s) in our database, spanning from 6/12/2017 to 8/2/2017.

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. RUI AN JIA QI POLARIZER CO., LTD's FEI number is 3010374980.

What types of violations has RUI AN JIA QI POLARIZER CO., LTD received?

RUI AN JIA QI POLARIZER CO., LTD has been cited for 1 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 RUI AN JIA QI POLARIZER CO., LTD come from?

All FDA import refusal data for RUI AN JIA QI POLARIZER 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.