Novo Nordisk Production Ireland Limited
⚠️ Moderate Risk
FEI: 3002806873 • Athlone, Co. Westmeath • IRELAND
FEI Number
3002806873
Location
Athlone, Co. Westmeath
Country
IRELANDAddress
Monksland Industrial Estate, , Athlone, Co. Westmeath, Ireland
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
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).
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.
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 |
|---|---|---|---|
| 8/24/2011 | 61TCF99ANTI-EMETIC/NAUSEANT N.E.C. | Division of Northern Border Imports (DNBI) | |
| 8/24/2011 | 61TCF99ANTI-EMETIC/NAUSEANT N.E.C. | Division of Northern Border Imports (DNBI) | |
| 5/27/2009 | 62GCC50NAPROXEN SODIUM (ANTI-INFLAMMATORY) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Novo Nordisk Production Ireland Limited's FDA import refusal history?
Novo Nordisk Production Ireland Limited (FEI: 3002806873) has 3 FDA import refusal record(s) in our database, spanning from 5/27/2009 to 8/24/2011.
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. Novo Nordisk Production Ireland Limited's FEI number is 3002806873.
What types of violations has Novo Nordisk Production Ireland Limited received?
Novo Nordisk Production Ireland Limited 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 Novo Nordisk Production Ireland Limited come from?
All FDA import refusal data for Novo Nordisk Production Ireland 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.