DU KANGMEDICAL TREATMENT COMPANY
⚠️ Moderate Risk
FEI: 3016668745 • Hebeiprov • CHINA
FEI Number
3016668745
Location
Hebeiprov
Country
CHINAAddress
Runjiang Edifice Yuhuad, , Hebeiprov, , 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
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.
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 DU KANGMEDICAL TREATMENT COMPANY's FDA import refusal history?
DU KANGMEDICAL TREATMENT COMPANY (FEI: 3016668745) has 1 FDA import refusal record(s) in our database, spanning from 4/28/2020 to 4/28/2020.
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. DU KANGMEDICAL TREATMENT COMPANY's FEI number is 3016668745.
What types of violations has DU KANGMEDICAL TREATMENT COMPANY received?
DU KANGMEDICAL TREATMENT COMPANY has been cited for 2 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 DU KANGMEDICAL TREATMENT COMPANY come from?
All FDA import refusal data for DU KANGMEDICAL TREATMENT COMPANY 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.