DAEYU VINA COMPANY LIMITED
⚠️ Moderate Risk
FEI: 3020906408 • Ha Nam Ha Nam • VIETNAM
FEI Number
3020906408
Location
Ha Nam Ha Nam
Country
VIETNAMAddress
Le Chan, Thi Son, Kim Bang, , Ha Nam Ha Nam, , Vietnam
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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/15/2021 | 77EWDPROTECTOR, HEARING (INSERT) | Division of Southwest Imports (DSWI) | |
| 12/15/2021 | 77EWDPROTECTOR, HEARING (INSERT) | Division of Southwest Imports (DSWI) | |
| 12/15/2021 | 77EWDPROTECTOR, HEARING (INSERT) | Division of Southwest Imports (DSWI) | |
| 12/15/2021 | 77EWDPROTECTOR, HEARING (INSERT) | Division of Southwest Imports (DSWI) | |
| 12/15/2021 | 77EWDPROTECTOR, HEARING (INSERT) | Division of Southwest Imports (DSWI) | |
| 12/15/2021 | 77EWDPROTECTOR, HEARING (INSERT) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is DAEYU VINA COMPANY LIMITED's FDA import refusal history?
DAEYU VINA COMPANY LIMITED (FEI: 3020906408) has 6 FDA import refusal record(s) in our database, spanning from 12/15/2021 to 12/15/2021.
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. DAEYU VINA COMPANY LIMITED's FEI number is 3020906408.
What types of violations has DAEYU VINA COMPANY LIMITED received?
DAEYU VINA COMPANY LIMITED has been cited for 2 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 DAEYU VINA COMPANY LIMITED come from?
All FDA import refusal data for DAEYU VINA COMPANY LIMITED 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.