Eclipse Limited
⚠️ High Risk
FEI: 3003671612 • Gore • NEW ZEALAND
FEI Number
3003671612
Location
Gore
Country
NEW ZEALANDAddress
43 Main St Level 1, , Gore, , New Zealand
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/25/2002 | 61EDY09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/25/2002 | 66NCY02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/25/2002 | 66NCY02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/25/2002 | 66NCY02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/25/2002 | 61JDY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/25/2002 | 61JDY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/25/2002 | 61JDY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/25/2002 | 60LCY83CELECOXIB (ANALGESIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/25/2002 | 60LCY83CELECOXIB (ANALGESIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/24/2002 | 62OCA04QUINAPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 66NCA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 66NCA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 66NCA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 60LCE83CELECOXIB (ANALGESIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 60LCE83CELECOXIB (ANALGESIC) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 62OCA04QUINAPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 115DR QUALITY | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Eclipse Limited's FDA import refusal history?
Eclipse Limited (FEI: 3003671612) has 19 FDA import refusal record(s) in our database, spanning from 10/17/2002 to 10/25/2002.
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. Eclipse Limited's FEI number is 3003671612.
What types of violations has Eclipse Limited received?
Eclipse 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 Eclipse Limited come from?
All FDA import refusal data for Eclipse 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.