Amgen, Inc.
⚠️ High Risk
FEI: 2026154 • Thousand Oaks, CA • UNITED STATES
FEI Number
2026154
Location
Thousand Oaks, CA
Country
UNITED STATESAddress
1 Amgen Center Dr, , Thousand Oaks, 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
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2025 | 58OCK12ROMOSOZUMAB-AQQG | Division of Southeast Imports (DSEI) | |
| 12/11/2025 | 62QCA99ANTI-RHEUMATIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/3/2025 | 58SCP15ETANERCEPT | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/3/2025 | 58MCP99IMMUNOLOGICAL AGENT, NEC | 179AGR RX | Division of West Coast Imports (DWCI) |
| 6/3/2025 | 63ADL05PARICALCITOL (BONE CALCIUM REGULATOR) | Division of Southeast Imports (DSEI) | |
| 5/19/2021 | 64OCY99MONOCLONAL ANTIBODIES, N.E.C. | 179AGR RX | Division of Southeast Imports (DSEI) |
| 3/25/2016 | 64YIK03PEGFILGRASTIM | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 6/20/2012 | 62DCB02PARATHYROID (INJ) (ANTI-HYPOCALCEMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/4/2008 | 60LCK99ANALGESIC, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/22/2006 | 62ZCY07FILGRASTIM | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/22/2006 | 61CCY08EPOETIN ALFA | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/22/2006 | 61CCY08EPOETIN ALFA | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/22/2006 | 61CCY08EPOETIN ALFA | 179AGR RX | New Orleans District Office (NOL-DO) |
| 5/26/2005 | 62GAJ99ANTI-INFLAMMATORY N.E.C. | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Amgen, Inc.'s FDA import refusal history?
Amgen, Inc. (FEI: 2026154) has 14 FDA import refusal record(s) in our database, spanning from 5/26/2005 to 12/17/2025.
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, Inc.'s FEI number is 2026154.
What types of violations has Amgen, Inc. received?
Amgen, Inc. has been cited for 4 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, Inc. come from?
All FDA import refusal data for Amgen, Inc. 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.