SCHERING DO BRASIL LTDA
⚠️ Moderate Risk
FEI: 3013232129 • Sao Paulo • BRAZIL
FEI Number
3013232129
Location
Sao Paulo
Country
BRAZILAddress
Canionevo de Everra 255, , Sao Paulo, , Brazil
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
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).
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
Frequently Asked Questions
What is SCHERING DO BRASIL LTDA's FDA import refusal history?
SCHERING DO BRASIL LTDA (FEI: 3013232129) has 1 FDA import refusal record(s) in our database, spanning from 1/27/2025 to 1/27/2025.
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. SCHERING DO BRASIL LTDA's FEI number is 3013232129.
What types of violations has SCHERING DO BRASIL LTDA received?
SCHERING DO BRASIL LTDA 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 SCHERING DO BRASIL LTDA come from?
All FDA import refusal data for SCHERING 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.