Daiichi Sankyo
⚠️ Moderate Risk
FEI: 3011164905 • Sao Paulosao Paulo • BRAZIL
FEI Number
3011164905
Location
Sao Paulosao Paulo
Country
BRAZILAddress
Av. Dr. Chucri Saidan 920 Torres15 Andar, , Sao Paulosao 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
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 Daiichi Sankyo's FDA import refusal history?
Daiichi Sankyo (FEI: 3011164905) has 2 FDA import refusal record(s) in our database, spanning from 11/24/2014 to 3/24/2016.
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. Daiichi Sankyo's FEI number is 3011164905.
What types of violations has Daiichi Sankyo received?
Daiichi Sankyo 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 Daiichi Sankyo come from?
All FDA import refusal data for Daiichi Sankyo 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.