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United Creation Optical Co., Ltd.

✅ Low Risk

FEI: 3003668653 • Kowloon Bay • HONG KONG

FEI

FEI Number

3003668653

📍

Location

Kowloon Bay

🇭🇰

Country

HONG KONG
🏢

Address

Flat C, 3/F, Yeung Yiu Chung (No. 8), Industrial Building, 20 Wang Hoi Rd., Kowloon Bay, , Hong Kong

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
5/30/2002
Latest Refusal
5/30/2002
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

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
5/30/2002
86HQZFRAME, SPECTACLE
118NOT LISTED
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is United Creation Optical Co., Ltd.'s FDA import refusal history?

United Creation Optical Co., Ltd. (FEI: 3003668653) has 1 FDA import refusal record(s) in our database, spanning from 5/30/2002 to 5/30/2002.

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. United Creation Optical Co., Ltd.'s FEI number is 3003668653.

What types of violations has United Creation Optical Co., Ltd. received?

United Creation Optical 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 United Creation Optical Co., Ltd. come from?

All FDA import refusal data for United Creation Optical 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.