Allergan Limited
⚠️ Moderate Risk
FEI: 1000263653 • High Wycombe, Buckinghamshire • UNITED KINGDOM
FEI Number
1000263653
Location
High Wycombe, Buckinghamshire
Country
UNITED KINGDOMAddress
The Crown Centre, Coronation Road, High Wycombe, Buckinghamshire, 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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 |
|---|---|---|---|
| 12/10/2007 | 60CCK54BRIMONIDINE TARTRATE (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/10/2007 | 60CCK54BRIMONIDINE TARTRATE (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/15/2005 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Allergan Limited's FDA import refusal history?
Allergan Limited (FEI: 1000263653) has 3 FDA import refusal record(s) in our database, spanning from 11/15/2005 to 12/10/2007.
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. Allergan Limited's FEI number is 1000263653.
What types of violations has Allergan Limited received?
Allergan 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 Allergan Limited come from?
All FDA import refusal data for Allergan 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.