Safilo Far East Ltd.
⚠️ Moderate Risk
FEI: 3001194879 • Sheung Wan, Hong Kong Island • HONG KONG
FEI Number
3001194879
Location
Sheung Wan, Hong Kong Island
Country
HONG KONGAddress
Unit 2303, Golden Centre; 188 Des Voeux Road Central, Sheung Wan, Hong Kong Island, 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).
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/1/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/23/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 8/26/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/17/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/25/2008 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 7/25/2003 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Florida District Office (FLA-DO) |
| 7/25/2003 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/7/2003 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 476NO REGISTR | Florida District Office (FLA-DO) |
| 8/7/2002 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Florida District Office (FLA-DO) | |
| 4/8/2002 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 476NO REGISTR | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Safilo Far East Ltd.'s FDA import refusal history?
Safilo Far East Ltd. (FEI: 3001194879) has 10 FDA import refusal record(s) in our database, spanning from 4/8/2002 to 2/1/2013.
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. Safilo Far East Ltd.'s FEI number is 3001194879.
What types of violations has Safilo Far East Ltd. received?
Safilo Far East Ltd. has been cited for 4 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 Safilo Far East Ltd. come from?
All FDA import refusal data for Safilo Far East 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.