Shanxi Hongjin Plastic Technology Co., Ltd
⚠️ Moderate Risk
FEI: 3013565389 • Linfen, Shanxi • CHINA
FEI Number
3013565389
Location
Linfen, Shanxi
Country
CHINAAddress
Qu', Coal Bed Gas Industrial Zone, Linfen, Shanxi, 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.
STD LABEL
The article appears to not bear labeling prescribed by the performance standard established under section 514.
Refusal History
Frequently Asked Questions
What is Shanxi Hongjin Plastic Technology Co., Ltd's FDA import refusal history?
Shanxi Hongjin Plastic Technology Co., Ltd (FEI: 3013565389) has 1 FDA import refusal record(s) in our database, spanning from 1/30/2024 to 1/30/2024.
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. Shanxi Hongjin Plastic Technology Co., Ltd's FEI number is 3013565389.
What types of violations has Shanxi Hongjin Plastic Technology Co., Ltd received?
Shanxi Hongjin Plastic Technology Co., Ltd 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 Shanxi Hongjin Plastic Technology Co., Ltd come from?
All FDA import refusal data for Shanxi Hongjin Plastic Technology 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.