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Xuzhou Booming Optical Spectacle Factory

✅ Low Risk

FEI: 3004409174 • Xuzhou, Jiangsu • CHINA

FEI

FEI Number

3004409174

📍

Location

Xuzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Zhongyin Bldg. Room 1612, # 99 Huaihaixi Road, Xuzhou, Jiangsu, China

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/16/2005
Latest Refusal
12/16/2005
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

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
12/16/2005
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Xuzhou Booming Optical Spectacle Factory's FDA import refusal history?

Xuzhou Booming Optical Spectacle Factory (FEI: 3004409174) has 1 FDA import refusal record(s) in our database, spanning from 12/16/2005 to 12/16/2005.

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. Xuzhou Booming Optical Spectacle Factory's FEI number is 3004409174.

What types of violations has Xuzhou Booming Optical Spectacle Factory received?

Xuzhou Booming Optical Spectacle Factory 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 Xuzhou Booming Optical Spectacle Factory come from?

All FDA import refusal data for Xuzhou Booming Optical Spectacle Factory 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.