FDA Investigator Mark C Saale
Mark C Saale has conducted inspections on 311 sites in 10 countries as of 14 Nov 2019. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
311
Last Inspection Date:
14 Nov 2019
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America,
Taiwan,
Netherlands,
Ukraine,
Italy,
Czechia,
Russian Federation,
South Africa,
India,
Germany
FDA Investigators that have inspected at least one site in common with Mark C Saale:
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,
Althea A Williams,
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 Tran,
Binh T Nguyen,
Bo Chi, PhD,
Bonnie I Needleman,
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,
Carrie A Hughes,
Caryn M Everly,
Caryn M Mcnab,
Cassandra L Abellard,
Cathleen A Carr Sharpe,
Cathryn M Groehnert,
Celena Ngo,
Charles L Larson,
Chelsea N Sealey,
Cheryl D Mccall,
Christina D Mello,
Christopher J Stannard,
Christopher R Czajka,
Cody D Rickman,
Comyar Shoghi,
Courtney N Long,
Craig T Rybus,
Crystal Monroy,
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,
Dolores Harper,
Donna Ltartaglino Besone,
Donna Mwilliams Hill, PhD,
Durell L Giles,
Dustin P Tran,
Dyana K Stone,
Edward Deberry,
Eileen T Dupont,
Elizabeth A Brown,
Elizabeth Ad Girard,
Ellen N Stewart,
Emily M Morrison,
Erik D Sandvig,
Esther B Gamallo Herrera,
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,
Henry E Carrillo,
Herminio C Francisco,
Himanshu Gupta, PhD,
Homero W Aguilar,
Hossein Khorshidi, PhD,
Humberto Z Gomez,
Iris C Macinnes,
Ivar J Sohn,
Ivis L Negron,
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,
Jessica L Pressley,
Jinnie Kokiatkulkij,
Jocelyn E Massey,
Jocelyn E Sparks,
Joel D Hustedt,
Joey V Quitania,
John A Daubenspeck,
John A Gonzalez,
John A Liu,
John L Stevens,
Jolanna A Norton,
Jonetta I Collins,
Jorge L Bertran,
Jose M Cayuela,
Joseph C Francisco,
Joseph C Yen,
Joseph H Lam,
Joseph M Willems,
Joseph S Fanelli,
Joshua P Wireman,
Juanita Banuelos,
Juanj N Wu,
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,
Laura A Munsterman,
LCDR Wilfred A Darang,
Leonard H Lavi,
Leticia I Romero,
Ligia M Cline,
Lillian S Wu,
Lilly O Barton,
Linda Thai,
Ling Yu L Liu,
Lisa Shin,
Lopez,
Loretta J Jordan,
Louis B Cencetti,
Lourdes Andujar,
Lucas B Leake,
Luis Mburgos Medero,
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 C Wall,
Mary E Farbman, PhD,
Mary Ewilkerson Brinsko,
Matthew J Johnson,
Maurice M Sheehan,
Maxyne T Lam,
Mei Chen Mu,
Meisha Waters,
Mendoza O Wallace,
Michael A Charles,
Michael D Garcia,
Michael F Schuette,
Michael S Araneta,
Michael S Call,
Michael T Cyrus,
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,
Qin Xu,
Rachael O Oyewole,
Rachel C Stanton,
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 Rloyd Jones,
Saied A Asbagh,
Saleem A Akhtar,
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, RAC,
Sparky L Bartee,
Srinivas R Chennamaneni, PhD,
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,
Susan T Hadman,
Susanna N Choi,
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 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,
Zhongren Wu
Mark C Saale's Documents
Publish Date | Document Type | Title |
---|---|---|
February, 2019 | EIR | Piramal Pharma Limited - EIR, 2019-02-08 |
November, 2007 | FDA 483 | Abbott Vascular Inc - Form 483, 2007-11-15 |
December, 2018 | EIR | Analys Lab Private Limited - EIR, 2018-12-21 |
July, 2007 | EIR | TWi Pharmaceuticals, Inc. - EIR, 2007-10-16 |
November, 2019 | EIR | Merz Pharma GmbH & Co KGaA - EIR, 2020-01-09 |
October, 2003 | EIR | Edward J. Jezbera, DVM - EIR, 2003-10-16 |
July, 2008 | EIR | Yuri Shvartz, M.D. - EIR, 2011-03-29 |
August, 2018 | EIR | Stephen G. Thein, Ph.D. - EIR, 2018-08-03 |
January, 2004 | FDA 483 | GAR Laboratories Inc. - Form 483, 2004-01-05 |
August, 2018 | FDA 483 | Stephen G. Thein, Ph.D. - Form 483, 2018-08-03 |
March, 2019 | EIR | Syn-Tech Chem. & Pharm. Co., Ltd - EIR, 2019-03-15 |
November, 2019 | FDA 483 | Merz Pharma GmbH & Co KGaA - Form 483, 2019-11-22 |
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.
![FDA Investigator Profile Icon](/images/InspectorProfile.png)
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