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Dongguan Shan Shin Glass Manufacturing Co., Ltd.

✅ Low Risk

FEI: 3003863629 • Dongguan City, Guangdong • CHINA

FEI

FEI Number

3003863629

📍

Location

Dongguan City, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Number 9 Tangdi Road, Lanbei, Chang Ping Town, Dongguan City, Guangdong, China

Low Risk

FDA Import Risk Assessment

21.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
1/12/2010
Latest Refusal
1/12/2010
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

3413×

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
1/12/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Los Angeles District Office (LOS-DO)
1/12/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Los Angeles District Office (LOS-DO)
1/12/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Dongguan Shan Shin Glass Manufacturing Co., Ltd.'s FDA import refusal history?

Dongguan Shan Shin Glass Manufacturing Co., Ltd. (FEI: 3003863629) has 3 FDA import refusal record(s) in our database, spanning from 1/12/2010 to 1/12/2010.

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. Dongguan Shan Shin Glass Manufacturing Co., Ltd.'s FEI number is 3003863629.

What types of violations has Dongguan Shan Shin Glass Manufacturing Co., Ltd. received?

Dongguan Shan Shin Glass Manufacturing 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 Dongguan Shan Shin Glass Manufacturing Co., Ltd. come from?

All FDA import refusal data for Dongguan Shan Shin Glass Manufacturing 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.