Fishel Toys Limited
✅ Low Risk
FEI: 1000336893 • Tsim Sha Tsui, Kowloon • HONG KONG
FEI Number
1000336893
Location
Tsim Sha Tsui, Kowloon
Country
HONG KONGAddress
17/F, Flat 1702, Harbour City World Commerce Centre; 11 Canton Road, Tsim Sha Tsui, Kowloon, 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 |
|---|---|---|---|
| 7/19/2004 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 7/19/2004 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 7/19/2004 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 7/19/2004 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Fishel Toys Limited's FDA import refusal history?
Fishel Toys Limited (FEI: 1000336893) has 4 FDA import refusal record(s) in our database, spanning from 7/19/2004 to 7/19/2004.
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. Fishel Toys Limited's FEI number is 1000336893.
What types of violations has Fishel Toys Limited received?
Fishel Toys Limited 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 Fishel Toys Limited come from?
All FDA import refusal data for Fishel Toys Limited 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.