Wah Ming Optical Mfy
✅ Low Risk
FEI: 3004724933 • Hong Kong • CHINA
FEI Number
3004724933
Location
Hong Kong
Country
CHINAAddress
3/F Kapok Industrial Bldg373 Tokowawan, , Hong Kong, , China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/18/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Wah Ming Optical Mfy's FDA import refusal history?
Wah Ming Optical Mfy (FEI: 3004724933) has 1 FDA import refusal record(s) in our database, spanning from 3/18/2016 to 3/18/2016.
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. Wah Ming Optical Mfy's FEI number is 3004724933.
What types of violations has Wah Ming Optical Mfy received?
Wah Ming Optical Mfy 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 Wah Ming Optical Mfy come from?
All FDA import refusal data for Wah Ming Optical Mfy 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.