Profit Country Enterprises Ltd
⚠️ Moderate Risk
FEI: 3003655280 • Kowloon • HONG KONG
FEI Number
3003655280
Location
Kowloon
Country
HONG KONGAddress
Rm 1, 16/F New Treasure Centre, , 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
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 |
|---|---|---|---|
| 9/27/2006 | 89IONEXERCISER, NON-MEASURING | 341REGISTERED | Florida District Office (FLA-DO) |
| 9/27/2006 | 89INPTIPS AND PADS, CANE, CRUTCH AND WALKER | 341REGISTERED | Florida District Office (FLA-DO) |
| 9/27/2006 | 89IKXAID, TRANSFER | 341REGISTERED | Florida District Office (FLA-DO) |
| 9/27/2006 | 89ILSADAPTOR, HYGIENE | 341REGISTERED | Florida District Office (FLA-DO) |
| 9/27/2006 | 89IPSCANE | 341REGISTERED | Florida District Office (FLA-DO) |
| 9/27/2006 | 89ITJWALKER, MECHANICAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 9/27/2006 | 89IPRCRUTCH | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Profit Country Enterprises Ltd's FDA import refusal history?
Profit Country Enterprises Ltd (FEI: 3003655280) has 7 FDA import refusal record(s) in our database, spanning from 9/27/2006 to 9/27/2006.
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. Profit Country Enterprises Ltd's FEI number is 3003655280.
What types of violations has Profit Country Enterprises Ltd received?
Profit Country Enterprises Ltd 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 Profit Country Enterprises Ltd come from?
All FDA import refusal data for Profit Country Enterprises 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.