SHENZHEN YIHONG LIGHTING CO LTD
✅ Low Risk
FEI: 3017208137 • Shenzhen, Guangdong • CHINA
FEI Number
3017208137
Location
Shenzhen, Guangdong
Country
CHINAAddress
F/2, 202 Building B, Shangwu Industrial Park, Shiyan Street, Shenzhen, Guangdong, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
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.
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).
Refusal History
Frequently Asked Questions
What is SHENZHEN YIHONG LIGHTING CO LTD's FDA import refusal history?
SHENZHEN YIHONG LIGHTING CO LTD (FEI: 3017208137) has 1 FDA import refusal record(s) in our database, spanning from 7/9/2021 to 7/9/2021.
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. SHENZHEN YIHONG LIGHTING CO LTD's FEI number is 3017208137.
What types of violations has SHENZHEN YIHONG LIGHTING CO LTD received?
SHENZHEN YIHONG LIGHTING 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 SHENZHEN YIHONG LIGHTING CO LTD come from?
All FDA import refusal data for SHENZHEN YIHONG LIGHTING 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.