Pfizer
⚠️ High Risk
FEI: 3027194079 • Manhattan, NY • UNITED STATES
FEI Number
3027194079
Location
Manhattan, NY
Country
UNITED STATESAddress
66 Hudson Blvd, , Manhattan, NY, United States
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/2/2025 | 62OCY12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2025 | 62OCY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 64RDY18HUMAN GROWTH HORMONE (HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2024 | 61NCA84DESVENLAFAXINE SUCCINATE | Division of Southeast Imports (DSEI) | |
| 8/5/2024 | 61LCA44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/23/2024 | 56ICY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/2/2024 | 56ECY20DOXYCYCLINE (TETRACYCLINES) | Division of Southeast Imports (DSEI) | |
| 12/11/2023 | 62VDY84NIRMATRELVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/19/2023 | 65KAL08LATANOPROST (PROSTAGLANDIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Pfizer's FDA import refusal history?
Pfizer (FEI: 3027194079) has 9 FDA import refusal record(s) in our database, spanning from 9/19/2023 to 12/2/2025.
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's FEI number is 3027194079.
What types of violations has Pfizer received?
Pfizer has been cited for 2 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 come from?
All FDA import refusal data for Pfizer 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.