Amacon Technogoes Ltd
⚠️ Moderate Risk
FEI: 3003084675 • United Kingdon • UNITED KINGDOM
FEI Number
3003084675
Location
United Kingdon
Country
UNITED KINGDOMAddress
7 Western Avenue Bus Park, , London,United Kingdon, , United Kingdom
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/1/2002 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | New Orleans District Office (NOL-DO) |
| 4/30/2002 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | New Orleans District Office (NOL-DO) |
| 4/30/2002 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | New Orleans District Office (NOL-DO) |
| 3/6/2002 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | New Orleans District Office (NOL-DO) |
| 3/6/2002 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | New Orleans District Office (NOL-DO) |
| 3/6/2002 | 95L32CD PLAYER COMBINATION SYSTEMS | 47NON STD | New Orleans District Office (NOL-DO) |
| 10/24/2001 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 10/9/2001 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 126FAILS STD | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Amacon Technogoes Ltd's FDA import refusal history?
Amacon Technogoes Ltd (FEI: 3003084675) has 8 FDA import refusal record(s) in our database, spanning from 10/9/2001 to 5/1/2002.
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. Amacon Technogoes Ltd's FEI number is 3003084675.
What types of violations has Amacon Technogoes Ltd received?
Amacon Technogoes Ltd has been cited for 3 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 Amacon Technogoes Ltd come from?
All FDA import refusal data for Amacon Technogoes 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.