Sandoz Do Brasil Industria Farma
⚠️ High Risk
FEI: 3011421288 • Cambe • 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 |
|---|---|---|---|
| 5/28/2025 | 65VCE56ZOLPIDEM TARTRATE (SEDATIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Sandoz Do Brasil Industria Farma's FDA import refusal history?
Sandoz Do Brasil Industria Farma (FEI: 3011421288) has 1 FDA import refusal record(s) in our database, spanning from 5/28/2025 to 5/28/2025.
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. Sandoz Do Brasil Industria Farma's FEI number is 3011421288.
What types of violations has Sandoz Do Brasil Industria Farma received?
Sandoz Do Brasil Industria Farma 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 Sandoz Do Brasil Industria Farma come from?
All FDA import refusal data for Sandoz Do Brasil Industria Farma 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.