VS Industry Vietnam Joint Stock Company
⚠️ Moderate Risk
FEI: 3009109991 • Bac Ninh City, Bac Ninh • VIETNAM
FEI Number
3009109991
Location
Bac Ninh City, Bac Ninh
Country
VIETNAMAddress
C1 - C2, Que Vo Industrial Park, Van Duong Ward, Bac Ninh City, Bac Ninh, 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).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
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).
Refusal History
Frequently Asked Questions
What is VS Industry Vietnam Joint Stock Company's FDA import refusal history?
VS Industry Vietnam Joint Stock Company (FEI: 3009109991) has 1 FDA import refusal record(s) in our database, spanning from 2/17/2023 to 2/17/2023.
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. VS Industry Vietnam Joint Stock Company's FEI number is 3009109991.
What types of violations has VS Industry Vietnam Joint Stock Company received?
VS Industry Vietnam Joint Stock Company 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 VS Industry Vietnam Joint Stock Company come from?
All FDA import refusal data for VS Industry Vietnam Joint Stock Company 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.