SHANDONG GUAN YING INDUSTRIAL
⚠️ Moderate Risk
FEI: 3016759896 • Shanndong Provi • CHINA
FEI Number
3016759896
Location
Shanndong Provi
Country
CHINAAddress
6 17 E Jiefang Rd, , Shanndong Provi, , 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is SHANDONG GUAN YING INDUSTRIAL's FDA import refusal history?
SHANDONG GUAN YING INDUSTRIAL (FEI: 3016759896) has 1 FDA import refusal record(s) in our database, spanning from 10/2/2024 to 10/2/2024.
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. SHANDONG GUAN YING INDUSTRIAL's FEI number is 3016759896.
What types of violations has SHANDONG GUAN YING INDUSTRIAL received?
SHANDONG GUAN YING INDUSTRIAL 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 SHANDONG GUAN YING INDUSTRIAL come from?
All FDA import refusal data for SHANDONG GUAN YING INDUSTRIAL 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.