Amgen, Inc
FDA inspection history in Thousand Oaks, California, 2003 to 2026
- 7
- Form 483s
- 3
- Warning letters
Every document, by year
- Warning letter
- Form 483
2003: one warning letter; 2014: one warning letter; 2015: one Form 483; 2016: one Form 483; 2017: two Form 483s; 2018: one Form 483; 2019: one Form 483; 2024: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2003One warning letter.
- 2014–19Six Form 483s and one warning letter, at Thousand Oaks, California.
- 2018The longest 483 on file: 7 observations over 3 pages at Thousand Oaks, California.
- 2024–26One Form 483 and one warning letter, at Thousand Oaks, California.
Cited most
Across all Amgen observations on file
- 21 CFR 211.67Equipment cleaning and maintenance6
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.192Production record review3
- 21 CFR 211.194Laboratory records2
The complete Amgen file.
All 10 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
Thousand Oaks, California
Seven Form 483s and two warning letters · 2014 to 2026 · 24 observations
Latest: Warning letter, Aug 12, 2026 →
Also: one document not tied to a site.
Documents
10 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-08-12 | Warning letter Warning letter | Thousand Oaks, California | — | $99 |
| 2024-02-06 | 483 Form 483 | Thousand Oaks, California | 5 | $99 |
| 2019-12-13 | 483 Form 483 | Thousand Oaks, California | 1 | $99 |
| 2018-03-16 | 483 Form 483 | Thousand Oaks, California | 7 | $99 |
| 2017-05-16 | 483 Form 483 | Thousand Oaks, California | 5 | $99 |
| 2017-02-17 | 483 Form 483 | Thousand Oaks, California | 1 | $99 |
| 2016-06-06 | 483 Form 483 | Thousand Oaks, California | 2 | $99 |
| 2015-05-22 | 483 Form 483 | Thousand Oaks, California | 3 | $99 |
| 2014-01-27 | Warning letter Warning letter | Thousand Oaks, California | — | $99 |
| 2003-05-09 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
Bo Chi (2)Carla J. Lundi (1)Davinna Ligons (1)Della Shin (1)Esther C. Broner (1)Frances Namuswe (1)Jee Y. Chung (1)Laura Fontan (1)Mohsen Rajabi Abhari (1)Roger F. Zabinski (1)Sarah Arden (1)Stanley Au (1)
FEI number 2026154 · most recent document Aug 12, 2026
About Amgen, Inc
How many FDA Form 483s has Amgen, Inc received?
FDA Intel has 7 Form 483s on file for Amgen, Inc; the most recent is dated Feb 6, 2024.
When was Amgen, Inc last inspected by FDA?
The most recent FDA inspection document on file for Amgen, Inc is a Form 483 dated Feb 6, 2024, for the site in Thousand Oaks, California.
What did FDA cite at Amgen, Inc?
The regulations cited most in the observations on file for Amgen, Inc are 21 CFR 211.67 (Equipment cleaning and maintenance), 6 times; 21 CFR 211.100 (Written procedures; deviations), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times.
Has Amgen, Inc received an FDA warning letter?
Yes. FDA Intel has 3 FDA warning letters on file for Amgen, Inc; the most recent is dated Aug 12, 2026.