Pfizer Ireland Pharmaceuticals
⚠️ High Risk
FEI: 3003348730 • Dublin 14, Co. DUBLIN • IRELAND
FEI Number
3003348730
Location
Dublin 14, Co. DUBLIN
Country
IRELANDAddress
Dun Laoghaire, Pottery Road, Dublin 14, Co. DUBLIN, Ireland
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
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).
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.
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
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 |
|---|---|---|---|
| 12/14/2025 | 64TCA12SIROLIMUS (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 61LCY44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/13/2017 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/20/2015 | 57HI42PNEUMOCOCCAL VACCINE | 71NO LICENSE | Cincinnati District Office (CIN-DO) |
| 7/20/2015 | 57HI42PNEUMOCOCCAL VACCINE | 71NO LICENSE | Cincinnati District Office (CIN-DO) |
| 2/25/2011 | 61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/17/2011 | 61JCC08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | Los Angeles District Office (LOS-DO) | |
| 2/17/2011 | 61JCC08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | Los Angeles District Office (LOS-DO) | |
| 10/10/2008 | 61JDA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pfizer Ireland Pharmaceuticals's FDA import refusal history?
Pfizer Ireland Pharmaceuticals (FEI: 3003348730) has 9 FDA import refusal record(s) in our database, spanning from 10/10/2008 to 12/14/2025.
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. Pfizer Ireland Pharmaceuticals's FEI number is 3003348730.
What types of violations has Pfizer Ireland Pharmaceuticals received?
Pfizer Ireland Pharmaceuticals 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 Pfizer Ireland Pharmaceuticals come from?
All FDA import refusal data for Pfizer Ireland Pharmaceuticals 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.