Zheijinag Lasy Science and Technology Co. Ltd
⚠️ Moderate Risk
FEI: 3010009404 • Jinhua, Zhejiang • CHINA
FEI Number
3010009404
Location
Jinhua, Zhejiang
Country
CHINAAddress
NO. 561 Chengdian Lu, Yiwu, Jinhua, Zhejiang, 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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
Frequently Asked Questions
What is Zheijinag Lasy Science and Technology Co. Ltd's FDA import refusal history?
Zheijinag Lasy Science and Technology Co. Ltd (FEI: 3010009404) has 1 FDA import refusal record(s) in our database, spanning from 2/21/2013 to 2/21/2013.
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. Zheijinag Lasy Science and Technology Co. Ltd's FEI number is 3010009404.
What types of violations has Zheijinag Lasy Science and Technology Co. Ltd received?
Zheijinag Lasy Science and Technology 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 Zheijinag Lasy Science and Technology Co. Ltd come from?
All FDA import refusal data for Zheijinag Lasy Science and 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.