ZHONGSHAN ZHENG NUO CO.,LTD
✅ Low Risk
FEI: 3017154619 • Zhongshan City • CHINA
FEI Number
3017154619
Location
Zhongshan City
Country
CHINAAddress
No. 71 Lefeng North Road, , Zhongshan 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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
Refusal History
Frequently Asked Questions
What is ZHONGSHAN ZHENG NUO CO.,LTD's FDA import refusal history?
ZHONGSHAN ZHENG NUO CO.,LTD (FEI: 3017154619) has 1 FDA import refusal record(s) in our database, spanning from 9/11/2020 to 9/11/2020.
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. ZHONGSHAN ZHENG NUO CO.,LTD's FEI number is 3017154619.
What types of violations has ZHONGSHAN ZHENG NUO CO.,LTD received?
ZHONGSHAN ZHENG NUO CO.,LTD has been cited for 5 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 ZHONGSHAN ZHENG NUO CO.,LTD come from?
All FDA import refusal data for ZHONGSHAN ZHENG NUO 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.