GZ VASINE ELECTRONIC TECH CO.
⚠️ Moderate Risk
FEI: 3013655468 • Hong Kong • HONG KONG
FEI Number
3013655468
Location
Hong Kong
Country
HONG KONGAddress
Tianhe Distr Gz, , Hong Kong, , Hong Kong
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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
NO TAG
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
Refusal History
Frequently Asked Questions
What is GZ VASINE ELECTRONIC TECH CO.'s FDA import refusal history?
GZ VASINE ELECTRONIC TECH CO. (FEI: 3013655468) has 1 FDA import refusal record(s) in our database, spanning from 10/3/2017 to 10/3/2017.
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. GZ VASINE ELECTRONIC TECH CO.'s FEI number is 3013655468.
What types of violations has GZ VASINE ELECTRONIC TECH CO. received?
GZ VASINE ELECTRONIC TECH CO. 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 GZ VASINE ELECTRONIC TECH CO. come from?
All FDA import refusal data for GZ VASINE ELECTRONIC TECH CO. 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.