Zibo Huiying Medical Products Co Ltd
⚠️ High Risk
FEI: 3017959296 • Zibo, Shandong • CHINA
FEI Number
3017959296
Location
Zibo, Shandong
Country
CHINAAddress
No. 3 Da Wu Road, Linzi, Zibo, Shandong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
3904
3905
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/22/2024 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of West Coast Imports (DWCI) | |
| 9/9/2024 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of West Coast Imports (DWCI) | |
| 7/12/2024 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 7/12/2024 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 7/12/2024 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 7/12/2024 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 4/1/2024 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northern Border Imports (DNBI) |
| 3/29/2024 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northern Border Imports (DNBI) |
| 3/14/2024 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Zibo Huiying Medical Products Co Ltd's FDA import refusal history?
Zibo Huiying Medical Products Co Ltd (FEI: 3017959296) has 9 FDA import refusal record(s) in our database, spanning from 3/14/2024 to 10/22/2024.
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. Zibo Huiying Medical Products Co Ltd's FEI number is 3017959296.
What types of violations has Zibo Huiying Medical Products Co Ltd received?
Zibo Huiying Medical Products Co Ltd has been cited for 6 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 Zibo Huiying Medical Products Co Ltd come from?
All FDA import refusal data for Zibo Huiying Medical 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.