Leung Kai Fook Medical Co Pte
⚠️ Moderate Risk
FEI: 3002762000 • Singapore, Singapore • SINGAPORE
FEI Number
3002762000
Location
Singapore, Singapore
Country
SINGAPOREAddress
577 Macpherson Road, Yun Chee Building, Singapore, Singapore, Singapore
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
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).
POISON PKG
The article appears to be a drug and its packaging and labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Refusal History
Frequently Asked Questions
What is Leung Kai Fook Medical Co Pte's FDA import refusal history?
Leung Kai Fook Medical Co Pte (FEI: 3002762000) has 3 FDA import refusal record(s) in our database, spanning from 5/3/2002 to 10/29/2021.
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. Leung Kai Fook Medical Co Pte's FEI number is 3002762000.
What types of violations has Leung Kai Fook Medical Co Pte received?
Leung Kai Fook Medical Co Pte has been cited for 3 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 Leung Kai Fook Medical Co Pte come from?
All FDA import refusal data for Leung Kai Fook Medical Co Pte 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.