FDA Investigator Mark C Saale
Mark C Saale has inspections in 10 countries as of 20 Nov 2023. Mark C Saale has collaborated with a combinined 5615 experts on various inspections, contributing to compliance and improvement across diverse sectors.
Investigator Details
Number of Inspected Sites:
310
Last Inspection Date:
20 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America,
India,
Czechia,
South Africa,
Russian Federation,
Netherlands,
Taiwan,
Italy,
Ukraine,
Germany
Co-Investigator(s):
A Williams,
Ademola O Daramola,
Aimee K Contreras,
Alan P Kurtzberg,
Albert Rodriguez,
Alexander M Kay,
Alexandra B Pitkin,
Alexandria L Capuano,
Aliza Chalapong Asawesna,
Allen F Hall,
Amanda L Fyles,
Amir Alavi,
Anastasia M Shields,
Anderson,
Angela Shepas,
Anthony G Emerson,
April P Shaw,
Arie C Menachem,
Armando Chavez, MS,
Arnold C Shih,
Ashar P Parikh,
Babajide Michael Osunsanmi,
Bapu R Gaddam,
Barbara J Rincon,
Belinda E Clifton,
Bichsa T Nguyen,
Bichsa T Tran,
Binh T Nguyen,
Blair,
Bo Chi, PhD,
Bonnie I Needleman,
Bowman,
Bradley E Tufto,
Brandon R Boone,
Brent W Higgs,
Brian P Putz,
Bruce W Benware,
Bryan A Galvez,
Burnsb,
Bush,
Carla J Lundi,
Carol B Czerniak,
Carr Sharpe,
Carrie A Hughes,
Caryn M Everly,
Caryn M Mcnab,
Cassandra L Abellard,
Cathryn M Groehnert,
Celena Ngo,
Charles L Larson,
Chelsea N Sealey,
Cheryl D Mccall,
Christina D Mello,
Christopher J Stannard,
Christopher R Czajka,
Comyar Shoghi,
Courtney N Long,
Craig T Rybus,
Daniel J Roberts,
Daniel R Solis,
Dannie E Rowland,
Darren S Brown,
Darrin E Davis,
David G Whitman,
David Serrano,
David Y Hernandez,
Davis,
Deborah A Greco,
Debra C Yamane,
Debra J Fracassa,
Dejon N Harris,
Dennis G Poertner,
Desiree C Iya,
Diana M Rand,
Diane Cvan Leeuwen,
Diane R Weidley,
Djamila Harouaka,
Donna Ltartaglino Besone,
Donna Mwilliams Hill,
Durell L Giles,
Dustin P Tran,
Dyana K Stone,
Edward Deberry,
Eileen T Dupont,
Elizabeth A Girard,
Elizabeth Ad Girard,
Ellen N Stewart,
Emily M Morrison,
Erik D Sandvig,
Esther B Gamallo Herrera,
F Alex Slizza,
Fe Q Reyes,
Finn A Slizza,
Francisco,
Garciam,
Garrad R Poole,
Gene D Arcy,
Gerald N Mcgirl, DDS,
Geraldine M Peregrin,
Greg K Keshishyan,
Gulshan R Anand,
Harperd,
Henry E Carrillo,
Herminio C Francisco,
Himanshu Gupta, PhD,
Hoover,
Hossein Khorshidi, PhD,
Humberto Z Gomez,
Iris C Macinnes,
Ivar J Sohn,
Ivis L Negron,
Ivis Lnegron Torres,
Jacobitz,
Jake T Lane,
James A Barreto,
James B Arnett,
James P Stallings,
James R Fleckenstein,
James S Cartwright,
Jamie M Du,
Jane S Wernberg,
Janet Pulver,
Jasmine N Thompson,
Jasmine Y Wang,
Jean Brewer,
Jeanne J Thai,
Jeannie Pradyanata,
Jeff M Uriarte,
Jeffrey P Raimondi,
Jennifer Crumb,
Jennifer M Gogley,
Jeremy Beber,
Jessica B Clark,
Jessica L Andrade,
Jinnie Kokiatkulkij,
Jocelyn E Massey,
Jocelyn E Sparks,
Joel D Hustedt,
Joey V Quitania,
John A Daubenspeck,
John A Gonzales,
John A Gonzalez,
John A Liu,
John L Stevens,
Jolanna A Norton,
Jonetta I Collins,
Jorge L Bertran,
Joseph C Francisco,
Joseph C Yen,
Joseph H Lam,
Joseph M Willems,
Joseph S Fanelli,
Joshua P Wireman,
Juanita Banuelos,
Judy C Nepsa,
Julia Ventura,
Julian C Hanson,
Ka L Wong,
Kai Wang,
Kari M Johansen,
Katherine E Jacobitz,
Kawshalya Pathiraja,
Kelley,
Kelvin Cheung,
Kelvin X Sanders,
Kevin Lee,
Kevin N Tran,
Kevin T Gerrity,
Kham Phommachanh,
Khang K Pham,
Khoa Nathanv Tran,
Kibily D Dembele,
Kim Lthomas Cruse,
Kimberly Lewandowski Walker,
Kimberly M Lichter,
Kirtida Patel,
Lakecha N Lewis,
Lam,
Lan T Tran,
Langer,
Laura A Munsterman,
LCDR Wilfred A Darang,
Lee,
Leonard H Lavi,
Leticia I Romero,
Ligia M Cline,
Lilly O Barton,
Linda Thai,
Ling Yul Liu,
Lisa Shin,
Lopez,
Loretta J Jordan,
Louis B Cencetti,
Louise B Cencetti,
Lourdes Andujar,
Lucas B Leake,
Lynda L Perry, PhD,
Mai X Huynh,
Marco A Solorio,
Marco S Esteves,
Marcus F Yambot,
Marie Falcone,
Marie T Falcone,
Mark A Tucker,
Mark Gray,
Mark W Babbitt,
Marlo Ianm Alintanahin,
Mary E Farbman, PhD,
Mary Ewilkerson Brinsko,
Matthew J Johnson,
Maurice M Sheehan,
Maxyne T Lam,
Mei Chen Mu,
Mendoza O Wallace,
Michael A Charles,
Michael D Garcia,
Michael F Schuette,
Michael S Araneta,
Michael S Call,
Michele R Douglas,
Michelle J Hines,
Mihaly S Ligmond,
Minh D Phan,
Monica R Maxwell,
Myers,
Myra K Casey,
Nancy E Byerly,
Natalie J Ayoub,
Natalie J Reese,
Naveen B Walker,
Ngoc T Le,
Nianna C Burns,
Nicholas J Lahey,
Nicholas L Hunt,
Norman Wong,
Pamela Y Lee,
Patricia F Alberico,
Patrick R Dimapindan,
Phal K Chhun,
Philip F Istafanos, DMV, MS,
Phillip L Toy,
Rachael O Oyewole,
Rachel E Hauser,
Ramon A Hernandez,
Randy L Elsberry,
Raymond T Oji,
Raymond W Brullo,
Rebecca Rodriguez,
Rebecca T Davis,
Richard W Tubb,
Richmond K Yip,
Robert C Coleman,
Robert C Hoover,
Robert D Tollefsen,
Robert S Sweeton,
Rochelle A Rolnik,
Rocio Guzman Velazquez,
Romero,
Ronald L Koller,
Ronda R Loyd Jones,
Saied A Asbagh,
Saleem A Akhtar,
Sandersk,
Sandra A Boyd,
Sandra L Shire, DMD, MPA,
Sangeeta M Khurana, PhD,
Sara Jdent Acosta,
Sarah A Hassas,
Scott J Matsuda,
Scott K Zika,
Sean P Desbrow,
Selene T Torres,
Shaquenta Y Perkins,
Sharon K Ferguson,
Sharon S Ho,
Sherri N Rohlf, MD,
Sonia R Peterson,
Sonya L Karsik,
Sparky L Bartee,
Srinivas R Chennamaneni, PhD,
State Agency,
Stephanie A Slater, MS,
Steven E Porter, Jr,
Sudipan Karmakar,
Sue Lee Chan,
Sumit Sen,
Sundy V Sedwick,
Sunita Vij,
Sunitha K Rajaram, PhD,
Susan K Bain,
Susanna N Choi,
Susant Hadman,
Taichun Qin, PhD,
Tamala P Bogan,
Tamala P Magee,
Tamara L Alexander,
Tanya E Malais,
Tara L Greene,
Tawny L Colling,
Terrance L Thomas,
Terrance P Nguyen,
Terri L Dodds,
Thanh B Tran,
Thao T Kwan,
Thomas R Beilke,
Thomas W Gordon,
Timothy P Lafave,
Timothy T Kapsala,
Trudy Papson,
Trudy R Papson,
Truong Xuan Nguyen (Andy),
Trushani T Desai,
Uttaniti Limchumroon (Tom),
Vanessa R Muller,
Vashti E Bocker,
Vickie L Anderson,
Victor H Loo,
Vilmary Negron Rodriguez,
Virgilio F Pacio, CSO,
Walden H Lee,
Wayne E Seifert,
Wayne L Jefferson,
Willemsj,
William J Leonard,
William S Vitale,
Wr Bowman,
Xiaohui Shen,
Yumi J Hiramine,
Yvette E Guillermo,
Yvette Mlacour Davis,
Yvonne T Lacour,
Yvonne Y Wu,
Zachary A Bogorad
Mark C Saale's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| August, 2018 | FDA 483 | Stephen G. Thein, Ph.D. - Form 483, 2018-08-03 |
| November, 2019 | EIR | Merz Pharma GmbH & Co KGaA - EIR, 2020-01-09 |
| August, 2018 | EIR | Stephen G. Thein, Ph.D. - EIR, 2018-08-03 |
| February, 2019 | EIR | Piramal Pharma Limited - EIR, 2019-02-08 |
| October, 2003 | EIR | Edward J. Jezbera, DVM - EIR, 2003-10-16 |
| November, 2007 | FDA 483 | Abbott Vascular - Form 483, 2007-11-15 |
| November, 2019 | FDA 483 | Merz Pharma GmbH & Co KGaA - Form 483, 2019-11-22 |
| December, 2018 | EIR | Analys Lab Private Limited - EIR, 2018-12-21 |
| January, 2004 | FDA 483 | GAR Laboratories Inc. - Form 483, 2004-01-05 |
| July, 2008 | EIR | Yuri Shvartz, M.D. - EIR, 2011-03-29 |
| March, 2019 | EIR | Syn-Tech Chem. & Pharm. Co., Ltd. - EIR, 2019-03-15 |
Experience Redica System's 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