Overview
- 28 FDA inspections are on record.
- 18 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-27.
At a glance
Inspections
28
Form 483s
18
EIRs
5
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Apr 2026 – 27 Apr 2026 | Human Drugs | 483 | On file |
| 20 Jun 2023 – 5 Jul 2023 | Human Drugs | 483 | View 483 → |
| 30 Aug 2021 – 8 Sep 2021 | Human Drugs | 483 | On file |
| 24 Feb 2020 – 27 Feb 2020 | Human Drugs | 483 | On file |
| 23 Sep 2019 – 27 Sep 2019 | Human Drugs | 483 | View 483 → |
| 30 Apr 2019 – 8 May 2019 | Human Drugs | 483 | On file |
| 1 Apr 2019 – 11 Apr 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Jul 2018 – 6 Aug 2018 | Human Drugs | 483 | On file |
| 12 Jul 2017 – 17 Jul 2017 | Medical Devices & Rad Health | Clean | |
| 26 Apr 2017 – 10 May 2017 | Human Drugs | 483 | On file |
| 18 Jan 2016 – 22 Jan 2016 | Human Drugs | 483 | On file |
| 3 Feb 2015 – 11 Feb 2015 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Jul 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Ivis L Negron Torres, Jose F Velez, Marian E Ramirez, Alan A Rivera
5 Jul 2023
21 CFR 211.166(a)(1)
Sample size - test intervals
Cited by Ivis L Negron Torres, Jose F Velez, Marian E Ramirez, Alan A Rivera
5 Jul 2023
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Ivis L Negron Torres, Jose F Velez, Marian E Ramirez, Alan A Rivera
27 Sep 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Noreen Muniz
Investigators
FDA investigators tied to this site in the record.
Jose E Melendez4 insp.
Alan A Rivera2 insp.
Jose F Velez2 insp.
Vilmary Negron Rodriguez2 insp.
Zachary L Stamm2 insp.
Santos E Camara1 insp.
Ivis L Negron Torres1 insp.
Marian E Ramirez1 insp.
Milva E Melendez Perales1 insp.
Zhong Li1 insp.
Noreen Muniz1 insp.
Maxwell L Van Tassell1 insp.
Jennifer Lalama1 insp.
Adaliz Santaliz-Cruz1 insp.
Nydia E Colon1 insp.
Jose A Lopez Rubet1 insp.
Michael Shanks1 insp.
Michael A Charles1 insp.
Paul Z Balcer1 insp.
Dennis Cantellops Paite1 insp.
Jose A Cruz Gonzalez1 insp.
Steven Fong1 insp.
Donald C Obenhuber1 insp.
Libia M Lugo1 insp.
Rafael Gonzalez1 insp.
Erika V Butler1 insp.
Steven C Madzo1 insp.
Colleen Thomas1 insp.
Ramon A Hernandez1 insp.
Rebecca E Dombrowski1 insp.
Jose R Lopez1 insp.
Rebecca Rodriguez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Amgen Manufacturing Limited LLC's 18 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