Guangbo Health & Leisure Equipment Factory
✅ Low Risk
FEI: 3008854104 • Guangzhou • CHINA
FEI Number
3008854104
Location
Guangzhou
Country
CHINAAddress
Xin Long Industry Area 12, , Guangzhou, , China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
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 Guangbo Health & Leisure Equipment Factory's FDA import refusal history?
Guangbo Health & Leisure Equipment Factory (FEI: 3008854104) has 1 FDA import refusal record(s) in our database, spanning from 4/23/2012 to 4/23/2012.
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. Guangbo Health & Leisure Equipment Factory's FEI number is 3008854104.
What types of violations has Guangbo Health & Leisure Equipment Factory received?
Guangbo Health & Leisure Equipment Factory 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 Guangbo Health & Leisure Equipment Factory come from?
All FDA import refusal data for Guangbo Health & Leisure Equipment Factory 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.