Celgene International Sarl
⚠️ Moderate Risk
FEI: 3006323509 • Boudry, Neuchatel • SWITZERLAND
FEI Number
3006323509
Location
Boudry, Neuchatel
Country
SWITZERLANDAddress
Route De Perreux 1, , Boudry, Neuchatel, Switzerland
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 Celgene International Sarl's FDA import refusal history?
Celgene International Sarl (FEI: 3006323509) has 3 FDA import refusal record(s) in our database, spanning from 11/16/2012 to 10/14/2021.
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. Celgene International Sarl's FEI number is 3006323509.
What types of violations has Celgene International Sarl received?
Celgene International Sarl 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 Celgene International Sarl come from?
All FDA import refusal data for Celgene International Sarl 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.