ZHANGJIAGANG FULULAI RUBBER-PLASTIC CO., LTD.
⚠️ Moderate Risk
FEI: 1000185441 • Zhangjiagang, Jiangsu • CHINA
FEI Number
1000185441
Location
Zhangjiagang, Jiangsu
Country
CHINAAddress
No. 35 Zhangshi Road, Fenghuang Town, Zhangjiagang, Jiangsu, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/7/2019 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/7/2019 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/7/2019 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/7/2019 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/7/2019 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/7/2019 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/7/2019 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/7/2019 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/7/2019 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/7/2019 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 8/7/2019 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
| 2/21/2018 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is ZHANGJIAGANG FULULAI RUBBER-PLASTIC CO., LTD.'s FDA import refusal history?
ZHANGJIAGANG FULULAI RUBBER-PLASTIC CO., LTD. (FEI: 1000185441) has 12 FDA import refusal record(s) in our database, spanning from 2/21/2018 to 8/7/2019.
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. ZHANGJIAGANG FULULAI RUBBER-PLASTIC CO., LTD.'s FEI number is 1000185441.
What types of violations has ZHANGJIAGANG FULULAI RUBBER-PLASTIC CO., LTD. received?
ZHANGJIAGANG FULULAI RUBBER-PLASTIC CO., LTD. has been cited for 1 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 ZHANGJIAGANG FULULAI RUBBER-PLASTIC CO., LTD. come from?
All FDA import refusal data for ZHANGJIAGANG FULULAI RUBBER-PLASTIC 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.