Zhenjiang Heyu Plastic and Rubber Co., Ltd.
⚠️ High Risk
FEI: 3005448862 • Yangzhong Jiangsu • CHINA
FEI
FEI Number
3005448862
📍
Location
Yangzhong Jiangsu
🇨🇳
Country
CHINA🏢
Address
Huangsangtao, , Yangzhong Jiangsu, , China
High Risk
FDA Import Risk Assessment
60.3
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
100
Total Refusals
3
Unique Violations
4/10/2015
Latest Refusal
6/26/2012
Earliest Refusal
Score Breakdown
Violation Severity
70.0×40%
Refusal Volume
74.2×30%
Recency
0.0×20%
Frequency
100.0×10%
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
47780×
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
278016×
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.
4794×
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/10/2015 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 4/10/2015 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 8/20/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 4/19/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 4/19/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 4/19/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 4/19/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 4/19/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 4/19/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southwest Imports (DSWI) |
| 1/23/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/23/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/14/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/14/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/11/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/9/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/9/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/9/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/9/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/9/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/9/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/9/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/9/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/9/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/9/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/9/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/9/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/9/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/8/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/8/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/8/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/8/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/8/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/8/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/8/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/8/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/7/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/7/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/7/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/7/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/7/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/7/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/4/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/4/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/4/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/4/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/4/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/4/2013 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/29/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 10/26/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/22/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/22/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/19/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/19/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/18/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/18/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/17/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/15/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/15/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/15/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/15/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/15/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/15/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/15/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/15/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/15/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/15/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/15/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/15/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/15/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/15/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/11/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/11/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/5/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of Southwest Imports (DSWI) |
| 10/5/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/5/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/5/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/4/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/4/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 9/27/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Southwest Import District Office (SWI-DO) |
| 9/24/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 9/14/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | San Francisco District Office (SAN-DO) |
| 6/26/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 479DV QUALITY | New York District Office (NYK-DO) |
| 6/26/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 479DV QUALITY | New York District Office (NYK-DO) |
| 6/26/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 479DV QUALITY | New York District Office (NYK-DO) |
| 6/26/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 479DV QUALITY | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Zhenjiang Heyu Plastic and Rubber Co., Ltd.'s FDA import refusal history?
Zhenjiang Heyu Plastic and Rubber Co., Ltd. (FEI: 3005448862) has 100 FDA import refusal record(s) in our database, spanning from 6/26/2012 to 4/10/2015.
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. Zhenjiang Heyu Plastic and Rubber Co., Ltd.'s FEI number is 3005448862.
What types of violations has Zhenjiang Heyu Plastic and Rubber Co., Ltd. received?
Zhenjiang Heyu Plastic and Rubber 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 Zhenjiang Heyu Plastic and Rubber Co., Ltd. come from?
All FDA import refusal data for Zhenjiang Heyu Plastic and Rubber 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.