GAOQUAN INDUSTRIAL XIAMEN CO LTD
✅ Low Risk
FEI: 3016976309 • Xia Men, Fujian • CHINA
FEI Number
3016976309
Location
Xia Men, Fujian
Country
CHINAAddress
901 Donglin Road Jimeinorth, Ji Mei District, Xia Men, Fujian, 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 |
|---|---|---|---|
| 7/16/2020 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GAOQUAN INDUSTRIAL XIAMEN CO LTD's FDA import refusal history?
GAOQUAN INDUSTRIAL XIAMEN CO LTD (FEI: 3016976309) has 1 FDA import refusal record(s) in our database, spanning from 7/16/2020 to 7/16/2020.
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. GAOQUAN INDUSTRIAL XIAMEN CO LTD's FEI number is 3016976309.
What types of violations has GAOQUAN INDUSTRIAL XIAMEN CO LTD received?
GAOQUAN INDUSTRIAL XIAMEN 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 GAOQUAN INDUSTRIAL XIAMEN CO LTD come from?
All FDA import refusal data for GAOQUAN INDUSTRIAL XIAMEN 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.