Guilin Zizhu Latex Co., Ltd
⚠️ Moderate Risk
FEI: 3002807119 • Guilin, Guangxizhuangzuzizhiqu • CHINA
FEI Number
3002807119
Location
Guilin, Guangxizhuangzuzizhiqu
Country
CHINAAddress
No. 6 Wushan Road, , Guilin, Guangxizhuangzuzizhiqu, 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.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/19/2012 | 85HISCONDOM | Los Angeles District Office (LOS-DO) | |
| 10/19/2012 | 85HISCONDOM | Los Angeles District Office (LOS-DO) | |
| 2/28/2012 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 9/23/2010 | 37BGT28BEAN CURD, DRIED (STICKS, SHEETS), (MULTIPLE FOOD SPECIALTIES, SIDE DISHES AND DESSERTS | 249FILTHY | New York District Office (NYK-DO) |
| 9/23/2010 | 37BGT28BEAN CURD, DRIED (STICKS, SHEETS), (MULTIPLE FOOD SPECIALTIES, SIDE DISHES AND DESSERTS | 249FILTHY | New York District Office (NYK-DO) |
| 9/7/2010 | 37BGT28BEAN CURD, DRIED (STICKS, SHEETS), (MULTIPLE FOOD SPECIALTIES, SIDE DISHES AND DESSERTS | 249FILTHY | New York District Office (NYK-DO) |
| 9/7/2010 | 37BGT28BEAN CURD, DRIED (STICKS, SHEETS), (MULTIPLE FOOD SPECIALTIES, SIDE DISHES AND DESSERTS | 249FILTHY | New York District Office (NYK-DO) |
| 6/29/2010 | 85HISCONDOM | 477HOLES | Division of Southeast Imports (DSEI) |
| 6/29/2010 | 85HISCONDOM | 477HOLES | Division of Southeast Imports (DSEI) |
| 10/20/2008 | 85HISCONDOM | 477HOLES | New England District Office (NWE-DO) |
| 2/12/2008 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 10/18/2006 | 85LTZCONDOM WITH NONOXYNOL-9 | 477HOLES | Philadelphia District Office (PHI-DO) |
| 6/21/2006 | 85HISCONDOM | 477HOLES | Los Angeles District Office (LOS-DO) |
| 4/25/2005 | 85HISCONDOM | Chicago District Office (CHI-DO) | |
| 1/31/2003 | 85HISCONDOM | 477HOLES | Detroit District Office (DET-DO) |
| 9/9/2002 | 85HISCONDOM | 477HOLES | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Guilin Zizhu Latex Co., Ltd's FDA import refusal history?
Guilin Zizhu Latex Co., Ltd (FEI: 3002807119) has 16 FDA import refusal record(s) in our database, spanning from 9/9/2002 to 10/19/2012.
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. Guilin Zizhu Latex Co., Ltd's FEI number is 3002807119.
What types of violations has Guilin Zizhu Latex Co., Ltd received?
Guilin Zizhu Latex 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 Guilin Zizhu Latex Co., Ltd come from?
All FDA import refusal data for Guilin Zizhu Latex 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.