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New Henry Optical Mfg Inc

✅ Low Risk

FEI: 3007142947 • Kwai Fong • HONG KONG

FEI

FEI Number

3007142947

📍

Location

Kwai Fong

🇭🇰

Country

HONG KONG
🏢

Address

Gloden Industrial Bldg, , Kwai Fong, , 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
10/8/2008
Latest Refusal
10/8/2008
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
10/8/2008
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is New Henry Optical Mfg Inc's FDA import refusal history?

New Henry Optical Mfg Inc (FEI: 3007142947) has 1 FDA import refusal record(s) in our database, spanning from 10/8/2008 to 10/8/2008.

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. New Henry Optical Mfg Inc's FEI number is 3007142947.

What types of violations has New Henry Optical Mfg Inc received?

New Henry Optical Mfg Inc 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 New Henry Optical Mfg Inc come from?

All FDA import refusal data for New Henry Optical Mfg Inc 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.