Topway Cargo Co Ltd
⚠️ Moderate Risk
FEI: 3007214663 • Fanling, New Territories • HONG KONG
FEI Number
3007214663
Location
Fanling, New Territories
Country
HONG KONGAddress
Rm 3, 3, F Poly Ctr; 15 Yip Fung Street, Fanling, New Territories, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/18/2010 | 66BAS44NICOTINE DELIVERY SYSTEM | Cincinnati District Office (CIN-DO) | |
| 8/21/2009 | 80KGXTAPE AND BANDAGE, ADHESIVE | Los Angeles District Office (LOS-DO) | |
| 12/5/2008 | 66BAS44NICOTINE DELIVERY SYSTEM | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Topway Cargo Co Ltd's FDA import refusal history?
Topway Cargo Co Ltd (FEI: 3007214663) has 3 FDA import refusal record(s) in our database, spanning from 12/5/2008 to 5/18/2010.
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. Topway Cargo Co Ltd's FEI number is 3007214663.
What types of violations has Topway Cargo Co Ltd received?
Topway Cargo Co Ltd has been cited for 4 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 Topway Cargo Co Ltd come from?
All FDA import refusal data for Topway Cargo 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.