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Shenzhen Ouke Xinxi Jisu Co Ltd

⚠️ Moderate Risk

FEI: 3010179084 • Shenzhen • CHINA

FEI

FEI Number

3010179084

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

150 Yufulou Dongyuan, , Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/23/2013
Latest Refusal
5/23/2013
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
5/23/2013
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
47NON STD
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Shenzhen Ouke Xinxi Jisu Co Ltd's FDA import refusal history?

Shenzhen Ouke Xinxi Jisu Co Ltd (FEI: 3010179084) has 1 FDA import refusal record(s) in our database, spanning from 5/23/2013 to 5/23/2013.

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. Shenzhen Ouke Xinxi Jisu Co Ltd's FEI number is 3010179084.

What types of violations has Shenzhen Ouke Xinxi Jisu Co Ltd received?

Shenzhen Ouke Xinxi Jisu 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 Shenzhen Ouke Xinxi Jisu Co Ltd come from?

All FDA import refusal data for Shenzhen Ouke Xinxi Jisu 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.