KANGTAI MEDICAL SYSTEM (QINHUANG
✅ Low Risk
FEI: 3017140509 • Qinhuangdao • CHINA
FEI Number
3017140509
Location
Qinhuangdao
Country
CHINAAddress
No 112 Qinhuang W St Qi, , Qinhuangdao, , 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).
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.
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).
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 KANGTAI MEDICAL SYSTEM (QINHUANG's FDA import refusal history?
KANGTAI MEDICAL SYSTEM (QINHUANG (FEI: 3017140509) has 1 FDA import refusal record(s) in our database, spanning from 10/20/2020 to 10/20/2020.
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. KANGTAI MEDICAL SYSTEM (QINHUANG's FEI number is 3017140509.
What types of violations has KANGTAI MEDICAL SYSTEM (QINHUANG received?
KANGTAI MEDICAL SYSTEM (QINHUANG 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 KANGTAI MEDICAL SYSTEM (QINHUANG come from?
All FDA import refusal data for KANGTAI MEDICAL SYSTEM (QINHUANG 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.