SHIJIAZHUANG BENESTAR PLASTIC CO., LTD
⚠️ Moderate Risk
FEI: 3007663054 • Shijiazhuang • CHINA
FEI Number
3007663054
Location
Shijiazhuang
Country
CHINAAddress
HELI NANNIU TOWN, ZHENGDING COUNTY, Shijiazhuang, , 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).
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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 SHIJIAZHUANG BENESTAR PLASTIC CO., LTD's FDA import refusal history?
SHIJIAZHUANG BENESTAR PLASTIC CO., LTD (FEI: 3007663054) has 2 FDA import refusal record(s) in our database, spanning from 3/18/2010 to 5/24/2010.
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. SHIJIAZHUANG BENESTAR PLASTIC CO., LTD's FEI number is 3007663054.
What types of violations has SHIJIAZHUANG BENESTAR PLASTIC CO., LTD received?
SHIJIAZHUANG BENESTAR PLASTIC 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 SHIJIAZHUANG BENESTAR PLASTIC CO., LTD come from?
All FDA import refusal data for SHIJIAZHUANG BENESTAR PLASTIC 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.