Zibo Tengyue Plastic Products Co., Ltd.
⚠️ Moderate Risk
FEI: 3009758390 • Zhangdian Zibo, Shandong • CHINA
FEI Number
3009758390
Location
Zhangdian Zibo, Shandong
Country
CHINAAddress
77 Center of Zhangdian Ave, , Zhangdian Zibo, Shandong, 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/4/2019 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of West Coast Imports (DWCI) | |
| 5/18/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 5/12/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 5/10/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 4/27/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northern Border Imports (DNBI) |
| 4/18/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 4/5/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 3/16/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southeast Imports (DSEI) |
| 12/30/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Chicago District Office (CHI-DO) |
| 6/20/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | New York District Office (NYK-DO) | |
| 6/18/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Zibo Tengyue Plastic Products Co., Ltd.'s FDA import refusal history?
Zibo Tengyue Plastic Products Co., Ltd. (FEI: 3009758390) has 11 FDA import refusal record(s) in our database, spanning from 6/18/2013 to 10/4/2019.
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 Tengyue Plastic Products Co., Ltd.'s FEI number is 3009758390.
What types of violations has Zibo Tengyue Plastic Products Co., Ltd. received?
Zibo Tengyue Plastic Products Co., Ltd. has been cited for 5 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 Tengyue Plastic Products Co., Ltd. come from?
All FDA import refusal data for Zibo Tengyue 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.