Hotelplus Amenities Mfgr Co Ltd
✅ Low Risk
FEI: 3007390334 • Kowloon Bay, Kowloon • HONG KONG
FEI Number
3007390334
Location
Kowloon Bay, Kowloon
Country
HONG KONGAddress
Telford House 2207, 16 Wang Hoi Road, Kowloon Bay, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/3/2010 | 76LXXKIT, TEST, PERIODONTAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Hotelplus Amenities Mfgr Co Ltd's FDA import refusal history?
Hotelplus Amenities Mfgr Co Ltd (FEI: 3007390334) has 1 FDA import refusal record(s) in our database, spanning from 8/3/2010 to 8/3/2010.
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. Hotelplus Amenities Mfgr Co Ltd's FEI number is 3007390334.
What types of violations has Hotelplus Amenities Mfgr Co Ltd received?
Hotelplus Amenities Mfgr Co 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 Hotelplus Amenities Mfgr Co Ltd come from?
All FDA import refusal data for Hotelplus Amenities Mfgr 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.