FDA Investigator Maria Gutierrez Lugo, PhD
Maria Gutierrez Lugo, PhD has conducted inspections on 7 sites in 5 countries as of 02 Sep 2019. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
7
Last Inspection Date:
02 Sep 2019
Investigator Role:
FDA Investigation Participant
Redica ID:
Countries of Inspections:
India,
Puerto Rico,
Korea (Republic of),
United States of America,
Austria
FDA Investigators that have inspected at least one site in common with Maria Gutierrez Lugo, PhD:
Adaliz Santaliz Cruz,
Alan A Rivera,
Alice S Tsao,
Alicia M Mozzachio,
Amy Devlin, PhD,
Anastasia G Lolas,
Andrea George, PhD,
Andrea Siegel, PhD,
Anita Narula, PhD,
Anjali Shukla, PhD,
Arlene M Badillo,
Arsen Karapetyan,
Ashley N Queen, PhD,
Barbara Janine Breithaupt,
Benjamin J Smith,
Bijoy Panicker,
Bo Chi, PhD,
Brian M Janelsins, PhD,
Brooke K Higgins,
Brooke K Seeman,
Bruce H Mccullough,
Calvin B Koerner,
Chaltu Nwakijra,
Charanjeet Jassal,
Christopher Downey, PhD,
Colleen Thomas, PhD,
David G Eng,
Deborah Schmiel, PhD,
Dennis Cantellops Paite,
Diane L Raccasi,
Dogbeda F Mackenzie,
Donald C Obenhuber, PhD,
Douglas A Campbell,
Dov H Pluznik, PhD,
Dr. Barbara D Paul, PhD,
Dr. Ralph M Bernstein, PhD,
Dr. Zhihao Qiu (Peter), PhD,
Edmund F Mrak, Jr,
Eileen A Liu,
Eliezar Ramos,
Emest F Bizjak,
Erika V Butler,
Frances Namuswe, PhD,
Geneve M Maxwell,
Geneve M Parks,
Gwyn G Dickinson,
Howard Anderson, PhD,
Hyung Yul Lee,
Ivis L Negron,
Jacek Cieslak, PhD,
James D Bridges,
James I Giefer,
Jazmine N Still,
Jee Chung, PhD,
Jeffrey A Sommers,
Jeffrey D Meng,
Jeffrey P Raimondi,
Jennifer C Adams,
Jennifer Lalama,
Jennifer Swisher, PhD,
Jerri Baker,
Joel D Martinez,
Jonathan W Chapman,
Jorge L Lajara,
Jose A Lopez,
Jose Acruz Gonzalez,
José E Meléndez,
Jose M Cayuela,
Jose R Lopez,
Jose Velez,
Kalavati Suvarna, PhD,
Kathy Lee,
Kevin A Gonzalez,
Kevin D Kallander,
Kevin P Foley,
Kristen Nickens, PhD,
Lakshmi Narasimhan, PhD,
Larry K Austin,
Laura Fontan, MS,
Laurel A Beer,
Laurie Nelson,
Lawrence J Stringer,
Libia M Lugo,
Linda F Murphy,
Lindsey Brown, PhD,
Lisa L Flores,
LT Rafael Gonzalez,
LT Richard A Lyght,
Lucila B Nwatu,
Luis A Dasta,
Madushini Dharmasena, PhD,
Margaret M Annes,
Maria Joselopez Barragan, PhD,
Marian E Ramirez,
Marion Michaelis,
Mary E Farbman, PhD,
Matthew B Casale,
Maxwell Van Tassell, PhD,
Meisha R Sampson,
Meisha Waters,
Melissa J Garcia,
Merry Christie, PhD,
Michael A Charles,
Michael G Truchan,
Michael Shanks, MS,
Michele L Forster, PhD,
Michelle Yclark Stuart,
Milva E Melendez Perales,
Monica Markovski, PhD,
Muna Algharibeh,
Muralidhara B Gavini, PhD,
Myriam M Sosa,
Nebil A Oumer,
Nicholas Obiri, PhD,
Nikolay Spiridonov,
Noreen Muñiz,
Nydia E Colon,
Omotunde O Osunsanmi,
Patricia F Hughes, PhD,
Patrick J Lynch,
Patrick L Wisor,
Patsy J Domingo,
Paul A Bonneau,
Paul Z Balcer,
Paula A Trost,
Phillip Angart, PhD,
Prabhu P Raju,
Rachel C Harrington,
Ramesh Potla, PhD,
Ramon A Hernandez,
Reba A Gates,
Rebecca E Dombrowski,
Rebecca Parrilla,
Rebecca Rodriguez,
Regina T Brown,
Reyes Candau Chacon, PhD,
Richard Ledwidge (nmi), PhD,
Riley C Myers, PhD,
Robert Darius,
Robert M Barbosa,
S Lori Brown, PhD MPH,
Sandra A Hughes,
Santos E Camara,
Sarah Arden,
Sarah Kennett, PhD,
Scott R Nichols, PhD,
Shadia Zaman, PhD,
Stephen D Eich,
Steven C Madzo,
Steven E Bowen, PhD,
Steven Fong, MS, PhD,
Susan M Jackson,
Susan T Hadman,
Susanne M Richardson, MS RAC,
Teegan Dellibovi Ragheb, PhD,
Thomas J Arista,
Thuy T Nguyen, LCDR,
Timothy Wadkin, PhD,
Vilmary Negron Rodriguez,
Virginia Carroll, PhD,
Wayne E Seifert,
Wendy G Tan, PhD,
Xianghong Jing (Emily), PhD,
Xiaoshi N Wang,
Yun Wu, PhD,
Zachary L Stamm,
Zhenzhen Liu, PhD,
Zhong Li, PhD
Maria Gutierrez Lugo, PhD's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| July, 2015 | FDA 483 | Human Genome Sciences, Inc. - Form 483, 2015-07-24 |
| September, 2014 | FDA 483 | Sandoz GmbH - Form 483, 2014-09-16 |
| March, 2014 | FDA 483 | Amgen Manufacturing Limited LLC - Form 483, 2014-03-29 |
| April, 2017 | FDA 483 | BIOCON LIMITED - Form 483, 2017-04-03 |
| April, 2013 | FDA 483 | Exelead, Inc. - Form 483, 2013-04-19 |
| September, 2019 | FDA 483 | Samsung Biologics Co., Ltd. - Form 483, 2019-09-10 |
| April, 2017 | FDA 483 | Biocon Biologics Limited - Form 483, 2017-04-07 |
Experience Redica Systems’ NEW investigator profiles and dashboards
Redica Systems customers get access to over 1,400 FDA Investigator profiles, containing powerful analysis like:
- Total inspections conducted
- 483 rate
- OAI rate
- Warning Letter rate
- Inspections by Industry, Scope, and Inspection Reason
- And much more
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.
Talk to sales to access our investigator profiles
Loading...
Investigator Profiles Are Just the Tip of the Iceberg
Becoming a Redica Systems customer not only provides you with unlimited access to profiles similar to the one above for every current and former FDA Investigator, 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