Amgen Manufacturing Limited LLC [Ceiba Norte / Puerto Rico]
Amgen Manufacturing Limited LLC [Ceiba Norte / Puerto Rico] located in CEIBA NORTE PUERTO RICO, Puerto Rico had its last known inspection on 05 Jul 2023. There are 33 known inspections on record.
Site Details
Industries:
Medical Devices,
Human Drugs,
Biologics
Tags:
Medical Devices,
Human Drugs,
Analytical Testing,
API Manufacturer,
Packaging,
Label,
Manufacturer,
FDF Manufacturer,
Sterile,
Biologics,
Biologics Manufacturer,
Biologics API Manufacturer
Last Inspection Date:
05 Jul 2023
FEI:
1000110364
Redica ID:
Investigators:
Robert Darius,
Michael Shanks, MS,
Calvin B Koerner,
Rebecca Parrilla,
Patricia F Hughes, PhD,
Milva E Melendez Perales,
Timothy Wadkin, PhD,
Paul Z Balcer,
Jerri Baker,
Jennifer Lalama,
Jose A Lopez,
Omotunde O Osunsanmi,
Michelle Yclark Stuart,
Zhong Li, PhD,
Jose Acruz Gonzalez,
Libia M Lugo,
Nicholas Obiri, PhD,
Maria Gutierrez Lugo, PhD,
Nikolay Spiridonov,
Wendy G Tan, PhD,
Andrea George, PhD,
Arlene M Badillo,
José E Meléndez,
Ivis L Negron,
Riley C Myers, PhD,
Paula A Trost,
Dennis Cantellops Paite,
Zachary L Stamm,
Eliezar Ramos,
Jose Velez,
Rebecca Rodriguez,
Jorge L Lajara,
Myriam M Sosa,
Christopher Downey, PhD,
Michael A Charles,
Nydia E Colon,
Dov H Pluznik, PhD,
Adaliz Santaliz Cruz,
Marian E Ramirez,
Noreen Muñiz,
Alan A Rivera,
Vilmary Negron Rodriguez,
LT Rafael Gonzalez,
Ramon A Hernandez,
Ashley N Queen, PhD,
Steven C Madzo,
Colleen Thomas, PhD,
Rebecca E Dombrowski,
Maxwell Van Tassell, PhD,
Erika V Butler,
Donald C Obenhuber, PhD,
Dr. Zhihao Qiu (Peter), PhD,
Jose R Lopez,
Steven Fong, MS, PhD,
Ramesh Potla, PhD,
Thomas J Arista
Amgen Manufacturing Limited LLC [Ceiba Norte / Puerto Rico]'s Most Recent Documents
| Publish Date | Document Type | Title |
|---|---|---|
| July, 2023 | FDA 483 Response | Amgen Manufacturing Limited LLC - Form 483R, 2023-07-19 |
| July, 2023 | FDA 483 | Amgen Manufacturing Limited LLC - Form 483, 2023-07-05 |
| September, 2021 | FDA 483 | Amgen Manufacturing Limited LLC - Form 483, 2021-09-08 |
| February, 2020 | EIR | Amgen Manufacturing Limited LLC - EIR, 2020-03-17 |
| February, 2020 | FDA 483 Response | Amgen Manufacturing Limited LLC - Form 483R, 2020-03-18 |
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