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Hsien Chang Optical Industrial Co., Ltd.

✅ Low Risk

FEI: 3003586769 • Tainan • TAIWAN

FEI

FEI Number

3003586769

📍

Location

Tainan

🇹🇼

Country

TAIWAN
🏢

Address

No. 31 Hsin Kang Hsin Fu Village, , Hsi Kang Hsiang, Tainan, , Taiwan

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
11/14/2018
Latest Refusal
11/14/2018
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
11/14/2018
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Hsien Chang Optical Industrial Co., Ltd.'s FDA import refusal history?

Hsien Chang Optical Industrial Co., Ltd. (FEI: 3003586769) has 1 FDA import refusal record(s) in our database, spanning from 11/14/2018 to 11/14/2018.

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. Hsien Chang Optical Industrial Co., Ltd.'s FEI number is 3003586769.

What types of violations has Hsien Chang Optical Industrial Co., Ltd. received?

Hsien Chang Optical Industrial 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 Hsien Chang Optical Industrial Co., Ltd. come from?

All FDA import refusal data for Hsien Chang Optical Industrial 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.