Broadway Trading Co
✅ Low Risk
FEI: 3003972052 • Wan Chai, Hong Kong Island • HONG KONG
FEI Number
3003972052
Location
Wan Chai, Hong Kong Island
Country
HONG KONGAddress
165-171 Wanchai Road, , Wan Chai, Hong Kong Island, Hong Kong
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/11/2003 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Broadway Trading Co's FDA import refusal history?
Broadway Trading Co (FEI: 3003972052) has 1 FDA import refusal record(s) in our database, spanning from 6/11/2003 to 6/11/2003.
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. Broadway Trading Co's FEI number is 3003972052.
What types of violations has Broadway Trading Co received?
Broadway Trading Co has been cited for 1 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 Broadway Trading Co come from?
All FDA import refusal data for Broadway Trading Co 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.