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XIAMEN SUNHAVEN OPTICAL CO LTD

⚠️ Moderate Risk

FEI: 3012295413 • Xiamen • CHINA

FEI

FEI Number

3012295413

📍

Location

Xiamen

🇨🇳

Country

CHINA
🏢

Address

56 Yangping Road Xinyan, , Xiamen, , China

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/30/2020
Latest Refusal
9/30/2020
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

Refusal History

DateProductViolationsDivision
9/30/2020
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is XIAMEN SUNHAVEN OPTICAL CO LTD's FDA import refusal history?

XIAMEN SUNHAVEN OPTICAL CO LTD (FEI: 3012295413) has 1 FDA import refusal record(s) in our database, spanning from 9/30/2020 to 9/30/2020.

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. XIAMEN SUNHAVEN OPTICAL CO LTD's FEI number is 3012295413.

What types of violations has XIAMEN SUNHAVEN OPTICAL CO LTD received?

XIAMEN SUNHAVEN OPTICAL 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 XIAMEN SUNHAVEN OPTICAL CO LTD come from?

All FDA import refusal data for XIAMEN SUNHAVEN OPTICAL 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.