Ninghai Beisan Low Voltage Electr
⚠️ Moderate Risk
FEI: 3006493755 • Ningboningbo • CHINA
FEI Number
3006493755
Location
Ningboningbo
Country
CHINAAddress
Ial Factory No.115 Xingongyiroad, , Ningboningbo, , 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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 Ninghai Beisan Low Voltage Electr's FDA import refusal history?
Ninghai Beisan Low Voltage Electr (FEI: 3006493755) has 2 FDA import refusal record(s) in our database, spanning from 7/2/2009 to 7/2/2009.
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. Ninghai Beisan Low Voltage Electr's FEI number is 3006493755.
What types of violations has Ninghai Beisan Low Voltage Electr received?
Ninghai Beisan Low Voltage Electr 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 Ninghai Beisan Low Voltage Electr come from?
All FDA import refusal data for Ninghai Beisan Low Voltage Electr 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.