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Zhuhai Haishen Import Export Co. Ltd

✅ Low Risk

FEI: 3011392503 • Zhuhai, Guangdong • CHINA

FEI

FEI Number

3011392503

📍

Location

Zhuhai, Guangdong

🇨🇳

Country

CHINA
🏢

Address

161 Summer Beauty Rd, , Zhuhai, Guangdong, China

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/1/2015
Latest Refusal
6/1/2015
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
6/1/2015
87HSTAPPARATUS, TRACTION, NON-POWERED
333LACKS FIRM
508NO 510(K)
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Zhuhai Haishen Import Export Co. Ltd's FDA import refusal history?

Zhuhai Haishen Import Export Co. Ltd (FEI: 3011392503) has 1 FDA import refusal record(s) in our database, spanning from 6/1/2015 to 6/1/2015.

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. Zhuhai Haishen Import Export Co. Ltd's FEI number is 3011392503.

What types of violations has Zhuhai Haishen Import Export Co. Ltd received?

Zhuhai Haishen Import Export Co. Ltd 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 Zhuhai Haishen Import Export Co. Ltd come from?

All FDA import refusal data for Zhuhai Haishen Import Export 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.