GUANGDONG YIAN TECHNOLOGY CO LTD
✅ Low Risk
FEI: 3017981783 • Dongguan City • CHINA
FEI Number
3017981783
Location
Dongguan City
Country
CHINAAddress
Ln 5 Qingshuiwa Hongfu, , Dongguan City, , China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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
Frequently Asked Questions
What is GUANGDONG YIAN TECHNOLOGY CO LTD's FDA import refusal history?
GUANGDONG YIAN TECHNOLOGY CO LTD (FEI: 3017981783) has 1 FDA import refusal record(s) in our database, spanning from 2/11/2021 to 2/11/2021.
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. GUANGDONG YIAN TECHNOLOGY CO LTD's FEI number is 3017981783.
What types of violations has GUANGDONG YIAN TECHNOLOGY CO LTD received?
GUANGDONG YIAN TECHNOLOGY 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 GUANGDONG YIAN TECHNOLOGY CO LTD come from?
All FDA import refusal data for GUANGDONG YIAN TECHNOLOGY 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.