Merck Sharp & Dohme LLC [Lansdale / United States of America]
Merck Sharp & Dohme LLC [Lansdale / United States of America] located in LANSDALE PENNSYLVANIA, United States of America under the [Merck & Co] organization had its last known inspection on 14 Oct 2022. There are 46 known inspections on record.
Site Details
Industries:
Biologics,
Human Drugs,
Animal Health
Tags:
Biologics,
Vaccines,
Human Drugs,
API Manufacturer,
Packaging,
Manufacturer,
Label,
Analytical Testing,
Biologics: Vaccines,
FDF Manufacturer,
Biologics Manufacturer,
Non-Clinical Lab (GLP),
Biologics: HCT/P,
Animal Health
Parent Organization:
Merck & Co
Last Inspection Date:
14 Oct 2022
FEI:
2510592
Redica ID:
Investigators:
Scott E Norris,
Simone E Pitts,
Kristen D Evans,
Robert B Shibuya, MD,
Alla Kachko, PhD,
Audrey Thereset Uy,
Helen B Ricalde,
Stephanie Mangigian, MS/OSH, RN,
LT John M Mastalski,
Ramon E Martinez,
Christopher J Adams,
Kelly N Kerr,
Ann Marie Montemurro,
Rebecca K Olin,
Cynthia Jim, CSO,
Chao Ming Tsai,
Omotunde O Osunsanmi,
James M Mason,
Julianne C Mccullough,
LCDR Margaret Edi Gennaro,
Eileen A Liu,
Haruhiko Murata,
Lisa M Feola,
Michael Curbarg,
Dave Hafner,
Jacqueline Mdiaz Albertini,
Gene D Arcy,
Karyn M Campbell,
Anita R Michael,
Xiao Wang,
Craig D Zagata,
Kathryn Carbone, MD,
Shuang Tang,
Michael Gurbarg,
Steven A Rubin,
Paula A Trost,
Christian D Lynch (CDL),
Junho Pak,
Christina J Sauder, PhD,
Mihaly S Ligmond,
Tina S Roecklein,
Robert D Tollefsen,
Prabhu P Raju,
Hala L Selby,
Anissa M Cheung,
Lisa M Bellows,
Ann L Demarco,
Stephen D Brown,
Rose Ashley,
Joan A Loreng,
Debra J Bennett,
Kathleen B Mihalik,
Vlada Matusovsky,
David J Hafner,
Brentley S Collins,
Susan F Laska, MS,
Ellen Huang,
Marian E Major, PhD,
Ann Marie Schofield,
Wei Wang, PhD,
J David Doleski,
Kenneth M Gordon,
Joan Adamo,
Joanne M Hajoway,
Sheila Dreher Lesnick,
CDR Jeremy L Wally, PhD,
Anastasia I Offordile,
Joseph George,
Linda Thai,
Tammy L Chavis,
Debra L Pagano,
Brian S Keefer
Merck Sharp & Dohme LLC [Lansdale / United States of America]'s Most Recent Documents
| Publish Date | Document Type | Title |
|---|---|---|
| August, 2024 | FDA 483 | Merck Sharp & Dohme LLC - Form 483, 2024-08-23 |
| July, 2021 | FDA 483 Response | Merck Sharp & Dohme LLC - Form 483R, 2021-08-09 |
| July, 2021 | FDA 483 | Merck Sharp & Dohme LLC - Form 483, 2021-07-27 |
| July, 2021 | EIR | Merck Sharp & Dohme LLC - EIR, 2021-07-27 |
| September, 2019 | EIR | Merck Sharp & Dohme LLC - EIR, 2019-09-20 |
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