Jinzhou City Xinrui Plastic Products Co., Ltd.
⚠️ Moderate Risk
FEI: 1000152173 • Jinzhou, Hebei • CHINA
FEI Number
1000152173
Location
Jinzhou, Hebei
Country
CHINAAddress
200 METERS EAST OF THE INTERSECTION OF CENTURY STREET AND 307 NATIONAL HIGHWAY, , Jinzhou, Hebei, 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.
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(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/7/2024 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of West Coast Imports (DWCI) | |
| 4/24/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 3/11/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northern Border Imports (DNBI) |
| 1/17/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 5/2/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Northern Border Imports (DNBI) | |
| 4/21/2015 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Northern Border Imports (DNBI) | |
| 4/21/2015 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Northern Border Imports (DNBI) | |
| 8/4/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 12/13/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Cincinnati District Office (CIN-DO) |
| 11/13/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Florida District Office (FLA-DO) |
| 10/13/2009 | 79KGOSURGEON'S GLOVES | 477HOLES | New York District Office (NYK-DO) |
| 8/25/2009 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 8/25/2009 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Jinzhou City Xinrui Plastic Products Co., Ltd.'s FDA import refusal history?
Jinzhou City Xinrui Plastic Products Co., Ltd. (FEI: 1000152173) has 13 FDA import refusal record(s) in our database, spanning from 8/25/2009 to 5/7/2024.
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. Jinzhou City Xinrui Plastic Products Co., Ltd.'s FEI number is 1000152173.
What types of violations has Jinzhou City Xinrui Plastic Products Co., Ltd. received?
Jinzhou City Xinrui 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 Jinzhou City Xinrui Plastic Products Co., Ltd. come from?
All FDA import refusal data for Jinzhou City Xinrui 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.