Amgen Manufacturing Limited LLC
⚠️ High Risk
FEI: 1000110364 • Juncos, PR • UNITED STATES
FEI Number
1000110364
Location
Juncos, PR
Country
UNITED STATESAddress
24.6 Carr 31, , Juncos, PR, 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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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 Manufacturing Limited LLC's FDA import refusal history?
Amgen Manufacturing Limited LLC (FEI: 1000110364) has 2 FDA import refusal record(s) in our database, spanning from 11/3/2025 to 12/9/2025.
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 Manufacturing Limited LLC's FEI number is 1000110364.
What types of violations has Amgen Manufacturing Limited LLC received?
Amgen Manufacturing Limited LLC 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 Amgen Manufacturing Limited LLC come from?
All FDA import refusal data for Amgen Manufacturing Limited LLC 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.