ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED
⚠️ High Risk
FEI: 3007923136 • Zibo, Shandong • CHINA
FEI Number
3007923136
Location
Zibo, Shandong
Country
CHINAAddress
Li Wang Village, Zhoujiazhen Huantaixian, 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.
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.
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.
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).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/24/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 6/24/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 6/24/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 6/14/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southeast Imports (DSEI) |
| 6/14/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southeast Imports (DSEI) |
| 6/12/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 6/12/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 6/12/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 6/12/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 6/12/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 6/12/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 6/12/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 6/12/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 6/4/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 6/4/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 6/4/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 6/4/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 6/3/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Northeast Imports (DNEI) | |
| 6/3/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Northeast Imports (DNEI) | |
| 6/3/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Northeast Imports (DNEI) | |
| 5/31/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 5/31/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 5/31/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 7/29/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | New York District Office (NYK-DO) |
| 7/29/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | New York District Office (NYK-DO) |
| 7/29/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | New York District Office (NYK-DO) |
| 7/29/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | New York District Office (NYK-DO) |
| 7/29/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | New York District Office (NYK-DO) |
| 7/29/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | New York District Office (NYK-DO) |
| 7/29/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | New York District Office (NYK-DO) |
| 7/29/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | New York District Office (NYK-DO) |
| 5/16/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | Florida District Office (FLA-DO) |
| 5/16/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | Florida District Office (FLA-DO) |
| 5/12/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 508NO 510(K) | Minneapolis District Office (MIN-DO) |
| 5/12/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 508NO 510(K) | Minneapolis District Office (MIN-DO) |
| 5/11/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 5/11/2011 | 80FMCGLOVE, PATIENT EXAMINATION | Baltimore District Office (BLT-DO) | |
| 5/11/2011 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED's FDA import refusal history?
ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED (FEI: 3007923136) has 38 FDA import refusal record(s) in our database, spanning from 5/11/2011 to 6/24/2019.
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 YUSHENG PLASTIC PRODUCTS COMPANY LIMITED's FEI number is 3007923136.
What types of violations has ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED received?
ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED 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 YUSHENG PLASTIC PRODUCTS COMPANY LIMITED come from?
All FDA import refusal data for ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED 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.