XIAMEN ASA SUNGLASSES CO., LTD
✅ Low Risk
FEI: 3012632739 • Xiamen • CHINA
FEI Number
3012632739
Location
Xiamen
Country
CHINAAddress
216 Huanzhu Rd, Fifth F, , Xiamen, , 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/25/2018 | 86HOISPECTACLE, MAGNIFYING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is XIAMEN ASA SUNGLASSES CO., LTD's FDA import refusal history?
XIAMEN ASA SUNGLASSES CO., LTD (FEI: 3012632739) has 1 FDA import refusal record(s) in our database, spanning from 9/25/2018 to 9/25/2018.
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. XIAMEN ASA SUNGLASSES CO., LTD's FEI number is 3012632739.
What types of violations has XIAMEN ASA SUNGLASSES CO., LTD received?
XIAMEN ASA SUNGLASSES CO., 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 XIAMEN ASA SUNGLASSES CO., LTD come from?
All FDA import refusal data for XIAMEN ASA SUNGLASSES 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.