Pfizer Ireland Pharmaceuticals Unlimited Company
⚠️ Moderate Risk
FEI: 3002807852 • Ringaskiddy, CORK • IRELAND
FEI Number
3002807852
Location
Ringaskiddy, CORK
Country
IRELANDAddress
Ringaskiddy Active Pharmaceutical Ingredient Plant, , Ringaskiddy, CORK, 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
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/18/2023 | 65PDY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2022 | 66SDA51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2019 | 64UCS99INHIBITOR N.E.C. | Division of Southeast Imports (DSEI) | |
| 1/30/2019 | 64UCS99INHIBITOR N.E.C. | Division of Southeast Imports (DSEI) | |
| 1/30/2019 | 64UCS99INHIBITOR N.E.C. | Division of Southeast Imports (DSEI) | |
| 1/30/2019 | 64UCS99INHIBITOR N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/19/2005 | 64GIS07ESTRADIOL (ESTROGEN) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Pfizer Ireland Pharmaceuticals Unlimited Company's FDA import refusal history?
Pfizer Ireland Pharmaceuticals Unlimited Company (FEI: 3002807852) has 7 FDA import refusal record(s) in our database, spanning from 9/19/2005 to 8/18/2023.
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 3002807852.
What types of violations has Pfizer Ireland Pharmaceuticals Unlimited Company received?
Pfizer Ireland Pharmaceuticals Unlimited Company 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 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.