DONGGUAN OUKANGDA MEDICAL TECHNOLOGY CO., LTD
⚠️ Moderate Risk
FEI: 3016834372 • Dongguan, Guangdong • CHINA
FEI Number
3016834372
Location
Dongguan, Guangdong
Country
CHINAAddress
Wende Street, Xiabian, , Dongguan, Guangdong, 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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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 DONGGUAN OUKANGDA MEDICAL TECHNOLOGY CO., LTD's FDA import refusal history?
DONGGUAN OUKANGDA MEDICAL TECHNOLOGY CO., LTD (FEI: 3016834372) has 1 FDA import refusal record(s) in our database, spanning from 9/29/2020 to 9/29/2020.
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. DONGGUAN OUKANGDA MEDICAL TECHNOLOGY CO., LTD's FEI number is 3016834372.
What types of violations has DONGGUAN OUKANGDA MEDICAL TECHNOLOGY CO., LTD received?
DONGGUAN OUKANGDA MEDICAL TECHNOLOGY CO., LTD 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 DONGGUAN OUKANGDA MEDICAL TECHNOLOGY CO., LTD come from?
All FDA import refusal data for DONGGUAN OUKANGDA MEDICAL 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.