Company
United StatesPublic company, NASDAQ: AMGNAmgen, Inc. (NASDAQ: AMGN), Thousand Oaks, CA – FDA Inspections
Inspection records and compliance data for Amgen, Inc. in Thousand Oaks, California. 30 FDA inspections on record (1 OAI), 6 Form 483s, 1 warning letter, last inspected August 07, 2025. Publicly traded as NASDAQ: AMGN.
Company Profile
This profile covers Amgen, Inc. based in Thousand Oaks, California, United States.
FDA Inspection History
- FDA inspections
- 30
- OAI
- 1
- VAI
- 6
- NAI
- 16
- Unclassified
- 7
- Form 483s
- 6
- Warning letters
- 1
First inspected May 1, 2009. Last inspected August 7, 2025.
Most cited issue areas
- Late submission of 15-day report2 inspections
- Acceptance of in-process materials1 inspection
- Cleaning SOP/inspection1 inspection
FDA inspections (30)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 7, 2025 | Not classified | Human Drugs | 1278976 |
| March 13, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1256132 |
| February 6, 2024 | Not classified | Human Drugs | 1240449 |
| September 14, 2023 | NAI | Human Drugs · Bioresearch Monitoring | 1220409 |
| December 13, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1112791 |
| March 16, 2018 | Not classified | Human Drugs | 1046609 |
| November 3, 2017 | Not classified | Human Drugs | 1036564 |
| October 3, 2017 | Not classified | Human Drugs | 1040847 |
| August 21, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1028320 |
| May 16, 2017 | Not classified | Human Drugs | 1017093 |
| April 19, 2017 | NAI | Human Drugs · Bioresearch Monitoring | 1014825 |
| April 19, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1014808 |
| March 17, 2017 | NAI | Human Drugs · Bioresearch Monitoring | 1008341 |
| February 17, 2017 | Not classified | Human Drugs | 1015989 |
| September 1, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 989425 |
| April 13, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 967048 |
| February 12, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 966245 |
| May 22, 2015 | VAI | Human Drugs · Drug Quality Assurance | 928588 |
| November 14, 2014 | NAI | Human Drugs · Bioresearch Monitoring | 904185 |
| September 17, 2014 | NAI | Human Drugs · Bioresearch Monitoring | 897046 |
| August 27, 2014 | NAI | Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring | 893531 |
| July 25, 2013 | NAI | Human Drugs · Bioresearch Monitoring | 843585 |
| June 17, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 837193 |
| December 12, 2012 | VAI | Human Drugs · Drug Quality Assurance | 811594 |
| December 12, 2012 | NAI | Human Drugs · Bioresearch Monitoring | 811581 |
| December 12, 2012 | VAI | Human Drugs · Bioresearch Monitoring | 810409 |
| May 20, 2011 | NAI | Human Drugs · Bioresearch Monitoring | 725867 |
| November 17, 2010 | NAI | Human Drugs · Bioresearch Monitoring | 697983 |
| June 3, 2010 | VAI | Human Drugs · Bioresearch Monitoring | 674567 |
| May 1, 2009 | NAI | Human Drugs · Bioresearch Monitoring | 579662 |
FDA documents
Form 483s (7)
Warning Letters (1)
EIRs (1)
Other FDA documents (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Amgen, Inc.
Stock ticker
AMGN
Exchange
NASDAQ
Share price
$467.06
Market cap
$252.6B
Price as of
November 13, 2026
FEI Number
2026154
Address
1 Amgen Center Dr, Thousand Oaks, California 91320, United States
Country
United States
ID: 85ec512e-6991-42ee-9cd5-148cfe0ed3e8