Shandong Yifan Plastic Products Co. Ltd
⚠️ Moderate Risk
FEI: 3010845275 • Zibo City, Shandong Province • CHINA
FEI Number
3010845275
Location
Zibo City, Shandong Province
Country
CHINAAddress
Bldg 11, Sunny Industries Park, Shuangyang Village, Zibo City, Shandong Province, 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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
Frequently Asked Questions
What is Shandong Yifan Plastic Products Co. Ltd's FDA import refusal history?
Shandong Yifan Plastic Products Co. Ltd (FEI: 3010845275) has 1 FDA import refusal record(s) in our database, spanning from 6/8/2017 to 6/8/2017.
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 Yifan Plastic Products Co. Ltd's FEI number is 3010845275.
What types of violations has Shandong Yifan Plastic Products Co. Ltd received?
Shandong Yifan Plastic Products Co. Ltd 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 Yifan Plastic Products Co. Ltd come from?
All FDA import refusal data for Shandong Yifan Plastic Products Co. Ltd 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.