Amgen Labpoint
⚠️ High Risk
FEI: 3002991564 • Newbury Park, CA • UNITED STATES
FEI Number
3002991564
Location
Newbury Park, CA
Country
UNITED STATESAddress
1 Amgen Center Dr, , Newbury Park, CA, United States
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
Frequently Asked Questions
What is Amgen Labpoint's FDA import refusal history?
Amgen Labpoint (FEI: 3002991564) has 2 FDA import refusal record(s) in our database, spanning from 4/14/2024 to 3/20/2025.
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. Amgen Labpoint's FEI number is 3002991564.
What types of violations has Amgen Labpoint received?
Amgen Labpoint 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 Amgen Labpoint come from?
All FDA import refusal data for Amgen Labpoint 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.