Hoi Tat Optical Mfy., Ltd.
⚠️ Moderate Risk
FEI: 3002847344 • Kowloon Bay, Kowloon • HONG KONG
FEI Number
3002847344
Location
Kowloon Bay, Kowloon
Country
HONG KONGAddress
Flat K, 10 Flat, Kai Tak Mansion Block 1; 53 Kwun Tong Road, Kowloon Bay, Kowloon, Hong Kong
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 |
|---|---|---|---|
| 12/27/2005 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 12/27/2005 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 12/27/2005 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Florida District Office (FLA-DO) |
| 12/27/2005 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/17/2004 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New York District Office (NYK-DO) |
| 6/17/2004 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Hoi Tat Optical Mfy., Ltd.'s FDA import refusal history?
Hoi Tat Optical Mfy., Ltd. (FEI: 3002847344) has 6 FDA import refusal record(s) in our database, spanning from 6/17/2004 to 12/27/2005.
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. Hoi Tat Optical Mfy., Ltd.'s FEI number is 3002847344.
What types of violations has Hoi Tat Optical Mfy., Ltd. received?
Hoi Tat Optical Mfy., 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 Hoi Tat Optical Mfy., Ltd. come from?
All FDA import refusal data for Hoi Tat Optical Mfy., 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.