Beijing HKKY Medical Tech. Co., Ltd.
⚠️ High Risk
FEI: 3013159466 • Beijing, Beijing • CHINA
FEI Number
3013159466
Location
Beijing, Beijing
Country
CHINAAddress
2/F,1 Building, No.21 Linhe Street,Linhe Industrial Development Zone, Shunyi District, Beijing, Beijing, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
FALSEDRUG
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug which is misbranded within the meaning of section 502(a)(1) in that its labeling is false or misleading.
Refusal History
Frequently Asked Questions
What is Beijing HKKY Medical Tech. Co., Ltd.'s FDA import refusal history?
Beijing HKKY Medical Tech. Co., Ltd. (FEI: 3013159466) has 2 FDA import refusal record(s) in our database, spanning from 10/26/2023 to 10/26/2023.
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. Beijing HKKY Medical Tech. Co., Ltd.'s FEI number is 3013159466.
What types of violations has Beijing HKKY Medical Tech. Co., Ltd. received?
Beijing HKKY Medical Tech. 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 Beijing HKKY Medical Tech. Co., Ltd. come from?
All FDA import refusal data for Beijing HKKY Medical Tech. 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.