Norbrook Laboratories Limited
⚠️ High Risk
FEI: 3005587188 • Newry, County Down • UNITED KINGDOM
FEI Number
3005587188
Location
Newry, County Down
Country
UNITED KINGDOMAddress
Carnbane Industrial Estate, , Newry, County Down, United Kingdom
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/18/2024 | 62GQY36FLUNIXIN (ANTI-INFLAMMATORY) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 8/15/2013 | 56YJK99ANTIBIOTIC N.E.C. | Division of Northeast Imports (DNEI) | |
| 8/15/2013 | 56YJK99ANTIBIOTIC N.E.C. | Division of Northeast Imports (DNEI) | |
| 11/15/2006 | 62GIR37FLUNIXIN MEGLUMINE (ANTI-INFLAMMATORY) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 10/27/2006 | 62GIR37FLUNIXIN MEGLUMINE (ANTI-INFLAMMATORY) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 2/6/2006 | 56LJN70TYLOSIN (NON-CERTIFIABLE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/15/2005 | 60QCS99ANESTHETIC, N.E.C. | New York District Office (NYK-DO) | |
| 8/30/2004 | 62GMS37FLUNIXIN MEGLUMINE (ANTI-INFLAMMATORY) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/21/2002 | 60LIS99ANALGESIC, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Norbrook Laboratories Limited's FDA import refusal history?
Norbrook Laboratories Limited (FEI: 3005587188) has 9 FDA import refusal record(s) in our database, spanning from 5/21/2002 to 3/18/2024.
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. Norbrook Laboratories Limited's FEI number is 3005587188.
What types of violations has Norbrook Laboratories Limited received?
Norbrook Laboratories Limited has been cited for 4 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 Norbrook Laboratories Limited come from?
All FDA import refusal data for Norbrook Laboratories 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.