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Xiamen Dynasty Optical Corp.,Ltd.

⚠️ Moderate Risk

FEI: 1000271731 • Xiamen, Fujian • CHINA

FEI

FEI Number

1000271731

📍

Location

Xiamen, Fujian

🇨🇳

Country

CHINA
🏢

Address

Huli Road, Huli Industrial District, Fu Hua Factory Xiamen, Xiamen, Fujian, 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
9/18/2002
Latest Refusal
9/18/2002
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
9/18/2002
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Xiamen Dynasty Optical Corp.,Ltd.'s FDA import refusal history?

Xiamen Dynasty Optical Corp.,Ltd. (FEI: 1000271731) has 1 FDA import refusal record(s) in our database, spanning from 9/18/2002 to 9/18/2002.

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 Dynasty Optical Corp.,Ltd.'s FEI number is 1000271731.

What types of violations has Xiamen Dynasty Optical Corp.,Ltd. received?

Xiamen Dynasty Optical Corp.,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 Dynasty Optical Corp.,Ltd. come from?

All FDA import refusal data for Xiamen Dynasty Optical Corp.,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.