YANGXI VENUS PPE MANUFACTURE
⚠️ Moderate Risk
FEI: 3016609597 • Yangjiang City • CHINA
FEI Number
3016609597
Location
Yangjiang City
Country
CHINAAddress
No 23 Industrial Zone Y, , Yangjiang 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
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/4/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of West Coast Imports (DWCI) | |
| 10/5/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | Division of Southeast Imports (DSEI) | |
| 9/21/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 9/21/2020 | 80NZJRESPIRATOR, N95, HOME USE | Division of Southeast Imports (DSEI) | |
| 9/11/2020 | 80NZJRESPIRATOR, N95, HOME USE | 3260NO ENGLISH | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is YANGXI VENUS PPE MANUFACTURE's FDA import refusal history?
YANGXI VENUS PPE MANUFACTURE (FEI: 3016609597) has 5 FDA import refusal record(s) in our database, spanning from 9/11/2020 to 11/4/2020.
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. YANGXI VENUS PPE MANUFACTURE's FEI number is 3016609597.
What types of violations has YANGXI VENUS PPE MANUFACTURE received?
YANGXI VENUS PPE MANUFACTURE 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 YANGXI VENUS PPE MANUFACTURE come from?
All FDA import refusal data for YANGXI VENUS PPE MANUFACTURE 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.