Merck Sharp & Dohme Farmaceutica Lt
⚠️ Moderate Risk
FEI: 3011133615 • Sousassousas • BRAZIL
FEI Number
3011133615
Location
Sousassousas
Country
BRAZILAddress
13 De Maio #1161, , Sousassousas, , 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
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 Merck Sharp & Dohme Farmaceutica Lt's FDA import refusal history?
Merck Sharp & Dohme Farmaceutica Lt (FEI: 3011133615) has 2 FDA import refusal record(s) in our database, spanning from 11/24/2014 to 11/24/2014.
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. Merck Sharp & Dohme Farmaceutica Lt's FEI number is 3011133615.
What types of violations has Merck Sharp & Dohme Farmaceutica Lt received?
Merck Sharp & Dohme Farmaceutica Lt 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 Merck Sharp & Dohme Farmaceutica Lt come from?
All FDA import refusal data for Merck Sharp & Dohme Farmaceutica Lt 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.