Amgen, Inc [Newbury Park / United States of America]
Amgen, Inc [Newbury Park / United States of America] located in NEWBURY PARK CALIFORNIA, United States of America had its last known inspection on 06 Feb 2024. There are 44 known inspections on record.
Site Details
Industries:
Biologics,
Human Drugs,
Medical Devices
Tags:
Biologics,
Human Drugs,
Biologics Manufacturer,
Medical Devices,
Combination Product,
FDF Manufacturer,
Medical Device Manufacturer,
Packaging,
Manufacturer,
Label,
Analytical Testing,
API Manufacturer,
Corporate Headquarters,
Sponsor,
Warehouse / Distributor,
Repackaging
Last Inspection Date:
06 Feb 2024
FEI:
2026154
Redica ID:
Investigators:
Robert Darius,
Donna Ltartaglino Besone,
Yvonne C Wilkes,
Kathleen R Jones, PhD,
Iris C Macinnes,
Brien C Fox,
Nicola M Fenty Stewart,
Mohsen Rajabi Abhari, FDA,
Michelle A Marsh,
Terri L Dodds,
Omotunde O Osunsanmi,
Sidney B Priesmeyer,
Haroon Vohra (NMI),
Frances Namuswe, PhD,
Kim Lthomas Cruse,
Thao X Tran,
Jeffrey P Raimondi,
Joel Welch, PhD,
Taichun Qin, PhD,
Diane Cvan Leeuwen,
Nicholas Obiri, PhD,
Haley H Seymour,
Christina C Santos,
Ronda Leblanc,
Tamika White,
Marcia B Williams,
Kendra A Biddick,
Sonia R Peterson,
Marcus F Yambot,
Roger F Zabinski,
Rona Leblanc, PhD,
Jennifer Gogley,
Richmond K Yip,
Laura Fontan, MS,
Kelvin Cheung,
Carla J Lundi,
Cheron M Portee,
Scott R Nichols, PhD,
Junho Pak,
John R Myung,
Mihaly S Ligmond,
Sarah Arden,
Rebecca Rodriguez,
Barry Cherney, PhD,
Ka L Wong,
Robert D Tollefsen,
Kelvin X Sanders,
Jennifer M Gogley,
Peter S Diak,
Amalia C Himaya,
Anita Narula, PhD,
Daniel W Cline,
Doan T Nguyen, PharmD,
Ronald L Koller,
Esther C Broner, PhD,
Jee Chung, PhD,
Uttaniti Limchumroon (Tom),
Thao T Kwan,
James R Fleckenstein,
Yumi J Hiramine,
Bichsa T Tran,
Davinna Ligons, PhD,
Caryn M Mcnab,
Christina V Santos,
Steven Fong, MS, PhD,
Leonard H Lavi,
Maxyne T Lam,
Bo Chi, PhD,
Stanley Au,
Hasan A Irier, PhD
Amgen, Inc [Newbury Park / United States of America]'s Most Recent Documents
| Publish Date | Document Type | Title |
|---|---|---|
| February, 2024 | FDA 483 | Amgen, Inc - Form 483, 2024-02-06 |
| December, 2019 | FDA 483 | Amgen, Inc - Form 483, 2019-12-13 |
| December, 2019 | EIR | Amgen, Inc - EIR, 2019-12-13 |
| December, 2019 | FDA 483 Response | Amgen, Inc - Form 483R, 2019-12-20 |
| March, 2018 | FDA 483 Response | Amgen, Inc - Form 483R, 2018-04-05 |
Experience Redica Systems’ NEW site dashboards and profiles
Redica Systems customers can leverage the full Quality and Regulatory Intelligence suite, with powerful analysis covering thousands of sites around the world. You can search by FEI, or more powerfully, by the Redica ID, our universal identifier for global life sciences manufacturing sites, an industry first.
Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.
Loading...
Site Profiles Are Just the Tip of the Iceberg
Becoming a Redica Systems customer not only provides you with unlimited access to our extensive inventory of site profiles, but also grants you access to:
Inspection Intelligence
- Pre-Approval Inspection (PAI) trends
- The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
- Latest 483s: see what the trends are across all FDA Investigators
- CFR Heatmap: Citations aggregated by Subpart by Year
Vendor Intelligence
- Full inspection histories for your vendors down to the specific site level
- All of the functionality mentioned above but isolated to just your vendors
Regulatory Intelligence
- Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
- All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more