Pfizer Ireland Pharmaceuticals Unlimited Company
⚠️ High Risk
FEI: 3006785053 • Newbridge, KILDARE • IRELAND
FEI Number
3006785053
Location
Newbridge, KILDARE
Country
IRELANDAddress
Little Connell, , Newbridge, KILDARE, 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).
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/15/2025 | 61LCY44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2025 | 61LCB44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2025 | 61LCY44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2025 | 61LCA44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2025 | 61LCA44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2025 | 61LCC44APIXABAN (ANTI-COAGULANT) | Division of West Coast Imports (DWCI) | |
| 5/10/2024 | 61LCY44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 66MCA86LORAZEPAM (TRANQUILIZER) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/28/2023 | 66MCA86LORAZEPAM (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/27/2023 | 61LCA44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/23/2022 | 66MCA03ALPRAZOLAM (TRANQUILIZER) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Pfizer Ireland Pharmaceuticals Unlimited Company's FDA import refusal history?
Pfizer Ireland Pharmaceuticals Unlimited Company (FEI: 3006785053) has 11 FDA import refusal record(s) in our database, spanning from 12/23/2022 to 9/15/2025.
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 Unlimited Company's FEI number is 3006785053.
What types of violations has Pfizer Ireland Pharmaceuticals Unlimited Company received?
Pfizer Ireland Pharmaceuticals Unlimited Company 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 Unlimited Company come from?
All FDA import refusal data for Pfizer Ireland Pharmaceuticals Unlimited Company 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.