Dongguan Union Button Co.Ltd.
⚠️ Moderate Risk
FEI: 3006447304 • Dongguang City • CHINA
FEI Number
3006447304
Location
Dongguang City
Country
CHINAAddress
Lu Dong Guanli Qu Humen Town, , Dongguang City, , China
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/28/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New York District Office (NYK-DO) | |
| 11/21/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 11/21/2013 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 11/21/2013 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Dongguan Union Button Co.Ltd.'s FDA import refusal history?
Dongguan Union Button Co.Ltd. (FEI: 3006447304) has 4 FDA import refusal record(s) in our database, spanning from 11/21/2013 to 4/28/2015.
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. Dongguan Union Button Co.Ltd.'s FEI number is 3006447304.
What types of violations has Dongguan Union Button Co.Ltd. received?
Dongguan Union Button Co.Ltd. has been cited for 3 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 Dongguan Union Button Co.Ltd. come from?
All FDA import refusal data for Dongguan Union Button 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.