Shenzhen Quro Electron Manufactory
⚠️ Moderate Risk
FEI: 3008004990 • Shenzhen, Guangdong • CHINA
FEI Number
3008004990
Location
Shenzhen, Guangdong
Country
CHINAAddress
F/2, NO 2 Building Eastern Technology; Baoan, Shenzhen, Guangdong, 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
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Refusal History
Frequently Asked Questions
What is Shenzhen Quro Electron Manufactory's FDA import refusal history?
Shenzhen Quro Electron Manufactory (FEI: 3008004990) has 1 FDA import refusal record(s) in our database, spanning from 8/9/2011 to 8/9/2011.
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. Shenzhen Quro Electron Manufactory's FEI number is 3008004990.
What types of violations has Shenzhen Quro Electron Manufactory received?
Shenzhen Quro Electron Manufactory 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 Shenzhen Quro Electron Manufactory come from?
All FDA import refusal data for Shenzhen Quro Electron Manufactory 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.