Pfizer S A S
⚠️ High Risk
FEI: 3011315460 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3011315460
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Av Suba 95 66, , Bogota, Cundinamarca, Colombia
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/27/2024 | 60LDE01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/27/2024 | 62GDE41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/11/2024 | 61NDA84DESVENLAFAXINE SUCCINATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/11/2024 | 66MDA86LORAZEPAM (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 56IDA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Pfizer S A S's FDA import refusal history?
Pfizer S A S (FEI: 3011315460) has 5 FDA import refusal record(s) in our database, spanning from 4/17/2020 to 9/27/2024.
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 A S's FEI number is 3011315460.
What types of violations has Pfizer S A S received?
Pfizer S A S has been cited for 1 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 S A S come from?
All FDA import refusal data for Pfizer S A S 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.