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Linhai City Yangchang Glasses Co., Ltd.

✅ Low Risk

FEI: 3010864813 • Fengdong Village Linhai City • CHINA

FEI

FEI Number

3010864813

📍

Location

Fengdong Village Linhai City

🇨🇳

Country

CHINA
🏢

Address

Duqiao Town, , Fengdong Village Linhai City, , 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
4/6/2015
Latest Refusal
4/6/2015
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

2311×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

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
4/6/2015
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Linhai City Yangchang Glasses Co., Ltd.'s FDA import refusal history?

Linhai City Yangchang Glasses Co., Ltd. (FEI: 3010864813) has 1 FDA import refusal record(s) in our database, spanning from 4/6/2015 to 4/6/2015.

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. Linhai City Yangchang Glasses Co., Ltd.'s FEI number is 3010864813.

What types of violations has Linhai City Yangchang Glasses Co., Ltd. received?

Linhai City Yangchang Glasses 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 Linhai City Yangchang Glasses Co., Ltd. come from?

All FDA import refusal data for Linhai City Yangchang Glasses 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.