Abbott Laboratorios Do Brasil Ltda
⚠️ High Risk
FEI: 3003641078 • Rio De Janeiro, Rio de Janeiro • BRAZIL
FEI Number
3003641078
Location
Rio De Janeiro, Rio de Janeiro
Country
BRAZILAddress
Estrada Dos Bandeirantes 2400, , Rio De Janeiro, Rio de Janeiro, Brazil
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 |
|---|---|---|---|
| 1/8/2025 | 61MCB35DIVALPROEX SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2015 | 62OCB13VERAPAMIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/14/2014 | 64ECB03PANCRELIPASE (ENZYME) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Abbott Laboratorios Do Brasil Ltda's FDA import refusal history?
Abbott Laboratorios Do Brasil Ltda (FEI: 3003641078) has 3 FDA import refusal record(s) in our database, spanning from 11/14/2014 to 1/8/2025.
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. Abbott Laboratorios Do Brasil Ltda's FEI number is 3003641078.
What types of violations has Abbott Laboratorios Do Brasil Ltda received?
Abbott Laboratorios Do Brasil Ltda 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 Abbott Laboratorios Do Brasil Ltda come from?
All FDA import refusal data for Abbott Laboratorios Do Brasil Ltda 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.