JINYI TECHNOLOGY CO LTD
⚠️ Moderate Risk
FEI: 3013682799 • Dongguan • CHINA
FEI Number
3013682799
Location
Dongguan
Country
CHINAAddress
128 Yongsheng Road Feng, , Dongguan, , 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).
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.
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 JINYI TECHNOLOGY CO LTD's FDA import refusal history?
JINYI TECHNOLOGY CO LTD (FEI: 3013682799) has 1 FDA import refusal record(s) in our database, spanning from 9/12/2017 to 9/12/2017.
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. JINYI TECHNOLOGY CO LTD's FEI number is 3013682799.
What types of violations has JINYI TECHNOLOGY CO LTD received?
JINYI TECHNOLOGY CO LTD has been cited for 3 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 JINYI TECHNOLOGY CO LTD come from?
All FDA import refusal data for JINYI 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.