Oxygen Limited
⚠️ Moderate Risk
FEI: 3003880945 • Wan Chai, Hong Kong Island • HONG KONG
FEI Number
3003880945
Location
Wan Chai, Hong Kong Island
Country
HONG KONGAddress
Sing-Ho Finance Building, 166 Gloucester Road, Wan Chai, Hong Kong Island, 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
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/4/2003 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | San Francisco District Office (SAN-DO) | |
| 2/4/2003 | 97Y35SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE | San Francisco District Office (SAN-DO) | |
| 2/4/2003 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Oxygen Limited's FDA import refusal history?
Oxygen Limited (FEI: 3003880945) has 3 FDA import refusal record(s) in our database, spanning from 2/4/2003 to 2/4/2003.
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. Oxygen Limited's FEI number is 3003880945.
What types of violations has Oxygen Limited received?
Oxygen Limited has been cited for 2 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 Oxygen Limited come from?
All FDA import refusal data for Oxygen 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.