Overview
- 38 FDA inspections are on record.
- 12 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-07.
At a glance
Inspections
38
Form 483s
12
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Aug 2025 – 7 Aug 2025 | Human Drugs | Clean | |
| 4 Mar 2025 – 13 Mar 2025 | Human Drugs | 483 | View 483 → |
| 29 Jan 2024 – 6 Feb 2024 | Human Drugs | 483 | On file |
| 11 Sep 2023 – 14 Sep 2023 | Human Drugs | Clean | |
| 9 Dec 2019 – 13 Dec 2019 | Human Drugs | 483 | View 483 → |
| 12 Mar 2018 – 16 Mar 2018 | Human Drugs | 483 | On file |
| 30 Oct 2017 – 3 Nov 2017 | Human Drugs | 483 | On file |
| 27 Sep 2017 – 3 Oct 2017 | Human Drugs | Clean | |
| 14 Aug 2017 – 21 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 8 May 2017 – 16 May 2017 | Human Drugs | 483 | On file |
| 11 Apr 2017 – 19 Apr 2017 | Human Drugs | Clean | |
| 13 Mar 2017 – 17 Mar 2017 | Human Drugs | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Mar 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Shawn E Larson, Michael T Cyrus, Rowena S Nguyen
13 Mar 2025
21 CFR 211.160(b)(2)
Acceptance of in-process materials
Cited by Shawn E Larson, Michael T Cyrus, Rowena S Nguyen
13 Mar 2025
21 CFR 211.192
No written record of investigation
Cited by Shawn E Larson, Michael T Cyrus, Rowena S Nguyen
13 Mar 2025
FDCA 582(b)(4)
Systems in place to comply with verification requirements
Cited by Shawn E Larson, Michael T Cyrus, Rowena S Nguyen
Investigators
FDA investigators tied to this site in the record.
Uttaniti Limchumroon7 insp.
James R Fleckenstein5 insp.
Bo Chi2 insp.
Taichun Qin2 insp.
Marcus F Yambot2 insp.
Leonard H Lavi2 insp.
Sonia R Peterson2 insp.
Caryn M Mcnab2 insp.
Maxyne T Lam2 insp.
Lan T Tran1 insp.
Shawn E Larson1 insp.
Michael T Cyrus1 insp.
Rowena S Nguyen1 insp.
Esther C Broner1 insp.
Iris C Macinnes1 insp.
Cheron M Portee1 insp.
Roger F Zabinski1 insp.
Anita Narula1 insp.
Hasan A Irier1 insp.
Kathleen R Jones1 insp.
Scott R Nichols1 insp.
Haroon Vohra1 insp.
Laura Fontan1 insp.
Jeffrey P Raimondi1 insp.
Diane C Van Leeuwen1 insp.
Stanley Au1 insp.
Nicola M Fenty-Stewart1 insp.
Haley H Seymour1 insp.
Peter S Diak1 insp.
Steven Fong1 insp.
Jennifer M Gogley1 insp.
Carla J Lundi1 insp.
Ka L Wong1 insp.
Doan T Nguyen1 insp.
Donna L Besone1 insp.
John R Myung1 insp.
Kelvin Cheung1 insp.
Kelvin X Sanders1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Amgen, Inc.'s 12 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat