WAI YUEN TONG MEDICINE CO., LTD.
⚠️ Moderate Risk
FEI: 3003457080 • Yau Tong, Kowloon • HONG KONG
FEI Number
3003457080
Location
Yau Tong, Kowloon
Country
HONG KONGAddress
11/F, Well Town Industrial Building; 13 Ko Fai Road, Yau Tong, Kowloon, Hong Kong
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
EPHEDALK
The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.
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).
Refusal History
Frequently Asked Questions
What is WAI YUEN TONG MEDICINE CO., LTD.'s FDA import refusal history?
WAI YUEN TONG MEDICINE CO., LTD. (FEI: 3003457080) has 2 FDA import refusal record(s) in our database, spanning from 10/25/2005 to 10/25/2005.
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. WAI YUEN TONG MEDICINE CO., LTD.'s FEI number is 3003457080.
What types of violations has WAI YUEN TONG MEDICINE CO., LTD. received?
WAI YUEN TONG MEDICINE 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 WAI YUEN TONG MEDICINE CO., LTD. come from?
All FDA import refusal data for WAI YUEN TONG MEDICINE 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.