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See Kiang Optical Manufactory Co. Ltd.

✅ Low Risk

FEI: 1000178620 • Tsuen Wan, Hong Kong • HONG KONG

FEI

FEI Number

1000178620

📍

Location

Tsuen Wan, Hong Kong

🇭🇰

Country

HONG KONG
🏢

Address

Rm.2001e-F Nan Fung Centre, 264-298 Castle Peak Rd., Tsuen Wan, Hong Kong, Hong Kong

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
10/2/2008
Latest Refusal
10/2/2008
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
10/2/2008
86HQZFRAME, SPECTACLE
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is See Kiang Optical Manufactory Co. Ltd.'s FDA import refusal history?

See Kiang Optical Manufactory Co. Ltd. (FEI: 1000178620) has 1 FDA import refusal record(s) in our database, spanning from 10/2/2008 to 10/2/2008.

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. See Kiang Optical Manufactory Co. Ltd.'s FEI number is 1000178620.

What types of violations has See Kiang Optical Manufactory Co. Ltd. received?

See Kiang Optical Manufactory 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 See Kiang Optical Manufactory Co. Ltd. come from?

All FDA import refusal data for See Kiang Optical Manufactory 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.