Dongguan Margotan Tech Co Ltd
⚠️ Moderate Risk
FEI: 3016446653 • Dongguan, Guangdong • CHINA
FEI Number
3016446653
Location
Dongguan, Guangdong
Country
CHINAAddress
Bldg 1 Rm 901, 1438 Tai'An Rd; Chang'An Town, Dongguan, 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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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.
Refusal History
Frequently Asked Questions
What is Dongguan Margotan Tech Co Ltd's FDA import refusal history?
Dongguan Margotan Tech Co Ltd (FEI: 3016446653) has 1 FDA import refusal record(s) in our database, spanning from 2/22/2024 to 2/22/2024.
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. Dongguan Margotan Tech Co Ltd's FEI number is 3016446653.
What types of violations has Dongguan Margotan Tech Co Ltd received?
Dongguan Margotan Tech Co Ltd has been cited for 2 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 Dongguan Margotan Tech Co Ltd come from?
All FDA import refusal data for Dongguan Margotan Tech 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.