Konbe Elec & Plastic Toys Fty
⚠️ Moderate Risk
FEI: 3006196977 • Dongguang • CHINA
FEI Number
3006196977
Location
Dongguang
Country
CHINAAddress
55 Yan Tian Dist, , Dongguang, , 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).
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 REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
Frequently Asked Questions
What is Konbe Elec & Plastic Toys Fty's FDA import refusal history?
Konbe Elec & Plastic Toys Fty (FEI: 3006196977) has 1 FDA import refusal record(s) in our database, spanning from 5/8/2007 to 5/8/2007.
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. Konbe Elec & Plastic Toys Fty's FEI number is 3006196977.
What types of violations has Konbe Elec & Plastic Toys Fty received?
Konbe Elec & Plastic Toys Fty 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 Konbe Elec & Plastic Toys Fty come from?
All FDA import refusal data for Konbe Elec & Plastic Toys Fty 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.