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Rui Rui Leopard Bicycle Accessor

✅ Low Risk

FEI: 3010459246 • Wenzhou • CHINA

FEI

FEI Number

3010459246

📍

Location

Wenzhou

🇨🇳

Country

CHINA
🏢

Address

201 Rm A1 3qi Xin Sheng Dong St, , Wenzhou, , China

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
1/3/2014
Latest Refusal
1/3/2014
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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).

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
1/3/2014
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
341REGISTERED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Rui Rui Leopard Bicycle Accessor's FDA import refusal history?

Rui Rui Leopard Bicycle Accessor (FEI: 3010459246) has 1 FDA import refusal record(s) in our database, spanning from 1/3/2014 to 1/3/2014.

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 Rui Leopard Bicycle Accessor's FEI number is 3010459246.

What types of violations has Rui Rui Leopard Bicycle Accessor received?

Rui Rui Leopard Bicycle Accessor 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 Rui Rui Leopard Bicycle Accessor come from?

All FDA import refusal data for Rui Rui Leopard Bicycle Accessor 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.