Guangzhou Double One Latex Products Co. Ltd
⚠️ Moderate Risk
FEI: 3002807127 • Guangzhou, Guangdong • CHINA
FEI Number
3002807127
Location
Guangzhou, Guangdong
Country
CHINAAddress
South Area of 3# Rubber Road Chini Town, Huadu District, , Guangzhou, Guangdong, 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
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).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
Refusal History
Frequently Asked Questions
What is Guangzhou Double One Latex Products Co. Ltd's FDA import refusal history?
Guangzhou Double One Latex Products Co. Ltd (FEI: 3002807127) has 3 FDA import refusal record(s) in our database, spanning from 10/6/2003 to 11/3/2008.
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. Guangzhou Double One Latex Products Co. Ltd's FEI number is 3002807127.
What types of violations has Guangzhou Double One Latex Products Co. Ltd received?
Guangzhou Double One Latex Products Co. Ltd has been cited for 4 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 Guangzhou Double One Latex Products Co. Ltd come from?
All FDA import refusal data for Guangzhou Double One Latex 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.