FDA Investigator Sherri N Rohlf, MD

Sherri N Rohlf, MD has inspections in 10 countries as of 15 Dec 2023. Sherri N Rohlf, MD has collaborated with a combinined 3538 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
157
Last Inspection Date:
15 Dec 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Poland, Belgium, Germany, Japan, France, India, Canada, Bulgaria
Co-Investigator(s):
Aaron J Poloni, Adam S Freeman, Alan P Kurtzberg, Alexander M Kay, Allan P Kurtzberg, Allen F Hall, Amanda E Lewin, PhD, Amber M Howell, Andersoneric, Angela Shepas, Anh Trinh T Nguyen, Anita Narula, PhD, Anthony E Keller, RPh, Armando Chavez, MS, Ashleigh P Barkans, Astrida B Mattson, Barbara J Rincon, Barbara Janine Breithaupt, Beau R Lamb, Betsy C Galliher, Bonita S Chester, Brenda L Reihing, Brenda L Reiling, Britton C Walker, Bryan Baker, Calvin K Cook, Carl A Anderson, Carla J Lundi, Carla V Jordan, CDR Thomas R Berry, PPh, Celia L Silverstein, Charles L Larson, Cheryl D Mccall, Christina D Mello, Christina L Norton, Christine I Shaw, Christine M Parmentier, Christopher S Genther, Connie P Rezendes, Courtney R Bratina, Craig T Rybus, Crystal A Harlan, Cynthia L Gorveatt, Dan G Eisenbrey, David R Heiar, Dawn E Barkans, Deborah A Nebenzahl, Deborah A Nebnzahl, Dennis G Kawabata, Devon M Shoop, Diane C Thibodeau, Diane Cvan Leeuwen, Dien N Nguyen, Dirk L Lincoln, Donald B Mckechnie, Douglas A Campbell, Durell L Giles, Dustin R Abaonza, Elizabeth S Howell, Eric L Scott, Eric M Mueller, PharmD, Felix Maldonado, Francis J Eng, Gajendiran Mahadevan, PhD, Gary L Zaharek, Gloria J Baca, MS, Graham N Giesen, Greg K Keshishyan, Harmon M Blanch, Heika R Tait, Herminio C Francisco, Hugh Grimoldby, Humberto Z Gomez, Ian J Thomson, James C Henry, James D Hildreth, James R Fleckenstein, James R Montero, James S Cartwright, James W Whitney, Jane M Kreis, Janet Pulver, Jeanne M Weishaar, Jeffrey J Leclair, Jenn W Sellers, Jessica L Kocian, Joan T Briones, Jocelyn E Massey, Jocelyn T Ramos, Joel D Martinez, John E Emmert, John S Hartford, John W Banks, Jonathan T Little, Joseph A Seitz, Julian C Hanson, Kara A Scheibner, PhD, Kathryn A Krentz, Katlin N Stubbs, Kenneth A Miles, Kent A Conforti, Kevin A Gonzalez, Kevin P Foley, Kimberly Lewandowski Walker, Kirstida Patel, Kirtida Patel, Kurt M Hafer, Lauren E Swantko, Leonard H Lavi, Linda S Leja, Linh Tu, Lisa K Capron, Lori J Silverstein, Lorna F Jones, M Patriciaurphy Murphy, Mai Hang, Maira P Brading, Marc R Dickens, Maria Pkelly Doggett, MBA, Marijo B Kambere, PhD, Mark C Saale, Mark E Imsland, Mark W Babbitt, Marlo Ianm Alintanahin, Mary Ewilkerson Brinsko, Mary R Hole, Maya M Davis, Melkamu Getie Kebtie, PhD, Mendoza O Wallace, Michael D Garcia, Michael J Lackey, Michelle J Hines, Michelle M Noe, Michelle Rfrazier Jessen, PhD, Mohsen Rajabi Abhari, FDA, Nancy A Saxenian Emmons, Nancy E Byerly, Nancy E Doyle, Nathan R Moon, Neali H Lucas, Nealie C Newberger, Neil J Traaen, Neira Acevedo Ramos, Paul F Rader, Paul L Yeh, Paul M Kawamoto, Paul R Whitby, Peter T Regan, Phal K Chhun, Philip E Ake, Philippe A Cornet, Phillip M Pontikos, Raffi B Papazian, Rebecca T Davis, Richmond K Yip, Robert D Tollefsen, Robert S Sweeton, Roger F Zabinski, Ronald E Gill, Ruben C Ayala, PharmD, S Lori Brown, PhD MPH, Sandra S Saniga, Savini, Scott A Nabe, Shannon J Hall, Shaquenta Y Perkins, Sharon I Gundersen, Shelley H Beausoleil, Sheri N Rohlf, Sherri N Rohif, Simone E Pitts, Stanley B Eugene, BS, BME, State Agency, Stephen R Souza, Sunitha K Rajaram, PhD, Sunny R Muir, Susanne M Richardson, MSc RAC ELS, Suyang Qin, Tawny L Colling, Teena H Aiken, Thao T Kwan, Thea C Grome, Thomas R Beilke, Timothy C Grome, Timothy P Lafave, Tracy K Li, Vanessa Y Gelsey, PhD, Vanessa Y Jacobs, Veronica Bush, Veronica L Bush, Victor A Meo, Victoria M Daddeo, Vining, Wayne T Smith, William J Foust, Xiaojun Yan, Yumi J Hiramine, Yvette E Guillermo, Zachary P Wachlarowicz

Sherri N Rohlf, MD's Documents

Publish Date Document Type Title
December, 2013 FDA 483 Pharma Tech Solutions, Inc - Form 483, 2013-12-09
September, 2014 FDA 483 FibroGen Incorporated - Form 483, 2014-09-19
January, 2018 FDA 483 Sam Van Boxstael, M.D. - Form 483, 2018-01-19
July, 2020 FDA 483 Philip M. Bolton, M.D. - Form 483, 2020-07-23
August, 2014 FDA 483 Rodo Medical, Inc. - Form 483, 2014-08-01
August, 2012 FDA 483 Response Michael E. Ring, MD - Form 483R, 2012-09-14
September, 2014 EIR FibroGen Incorporated - EIR, 2014-09-19
August, 2021 FDA 483 Augusto E. Focil, M.D. - Form 483, 2021-08-27
August, 2015 FDA 483 Andrew Blauvelt, MD, MBA - Form 483, 2015-08-10
June, 2014 FDA 483 Solta Medical, Inc. - Form 483, 2014-06-17
March, 2020 FDA 483 Kyowa Kirin Pharmaceutical Research, Inc. - Form 483, 2020-03-06
December, 2014 FDA 483 Makoto Tahara, MD, PhD - Form 483, 2014-12-05
November, 2018 FDA 483 May Y. Huang, M.D. - Form 483, 2018-11-29
April, 2021 FDA 483 Response Brock A. McConnehey, DO - Form 483R, 2021-04-07
June, 2011 FDA 483 Inovise Medical, Inc. - Form 483, 2011-06-01
September, 2013 EIR James W. Baker, MD - EIR, 2013-09-19
August, 2014 FDA 483 Response Rodo Medical, Inc. - Form 483R, 2014-08-21
June, 2022 FDA 483 Christine H. Lee, M.D. - Form 483, 2022-06-17
February, 2019 FDA 483 Mitali Wadekar, M.D. - Form 483, 2019-02-01
May, 2016 FDA 483 Response James W. Baker, MD - Form 483R, 2016-06-16
August, 2023 FDA 483 Mark A. Stein, Ph.D. - Form 483, 2023-08-04
April, 2013 EIR Arifulla Khan MD - EIR, 2013-04-10
September, 2013 FDA 483 Response James W. Baker, MD - Form 483R, 2013-10-08
August, 2010 FDA 483 Philips North America LLC - Form 483, 2010-08-09
April, 2013 FDA 483 Arifulla Khan MD - Form 483, 2013-04-10
June, 2017 FDA 483 Response James W. Baker, MD - Form 483R, 2017-07-10
August, 2021 FDA 483 David L. Wirta, M.D. - Form 483, 2021-08-13
August, 2010 EIR Philips North America LLC - EIR, 2012-08-29
August, 2021 EIR Augusto E. Focil, M.D. - EIR, 2021-08-27
August, 2019 FDA 483 Tooraj J. Raoof, M.D. - Form 483, 2019-08-02
December, 2020 EIR Andrew Blauvelt, MD, MBA - EIR, 2020-12-08
January, 2018 FDA 483 Krzysztof Wilk, M.D., Ph.D. - Form 483, 2018-01-26
September, 2013 FDA 483 James W. Baker, MD - Form 483, 2013-09-19
February, 2017 FDA 483 Patricia L. Norris, MD - Form 483, 2017-02-10
May, 2021 FDA 483 Chafic Karam, M.D. - Form 483, 2021-05-03
May, 2016 EIR James W. Baker, MD - EIR, 2016-05-26
October, 2015 FDA 483 Cheta Nand, M.D. - Form 483, 2015-11-19
April, 2012 FDA 483 Commed, Inc. - Form 483, 2012-04-02
April, 2016 FDA 483 Bruno Carneiro De Medeiros, M.D. - Form 483, 2016-04-29
October, 2022 FDA 483 Maria W. Greenwald, MD - Form 483, 2022-10-27
April, 2021 FDA 483 Brock A. McConnehey, DO - Form 483, 2021-04-02
April, 2022 FDA 483 Sant P. Chawla, MD - Form 483, 2022-04-15
June, 2017 FDA 483 James W. Baker, MD - Form 483, 2017-09-20
April, 2018 FDA 483 Calcagno, Frank A. MD - Form 483, 2018-04-30
August, 2012 FDA 483 Michael E. Ring, MD - Form 483, 2012-09-13
November, 2014 FDA 483 Alexander E. Horwitz, III, M.D. - Form 483, 2014-11-14
December, 2014 FDA 483 Eun Kyung Lee, MD, PhD - Form 483, 2014-12-12
December, 2012 FDA 483 Ocular Concepts LLC - Form 483, 2012-12-05
February, 2017 EIR Patricia L. Norris, MD - EIR, 2017-02-10
February, 2012 FDA 483 Global Pathogen Solutions, Inc - Form 483, 2012-02-28
January, 2013 FDA 483 Genesis Northwest, Incorporated - Form 483, 2013-02-22
October, 2017 FDA 483 UNIVERSITY OF OREGON - Form 483, 2017-10-17
December, 2012 FDA 483 Maloney's Custom Ocular Prosthetics - Form 483, 2012-12-05
June, 2021 EIR Stephen G. Thein, Ph.D. - EIR, 2021-06-18
May, 2022 FDA 483 Brock A. Andersen, M.D. - Form 483, 2022-05-20
August, 2012 EIR Michael E. Ring, MD - EIR, 2012-08-23
December, 2022 FDA 483 Joshua M. Smith, M.D., MBA - Form 483, 2022-12-08
October, 2019 FDA 483 Roger A. Dailey, M.D. - Form 483, 2019-10-02
March, 2019 FDA 483 Mohammad A. Mahmud, M.D. - Form 483, 2019-03-01
July, 2021 FDA 483 Sujith R. Kalmadi, MD - Form 483, 2021-07-16
April, 2021 EIR Brock A. McConnehey, DO - EIR, 2021-04-02
February, 2017 FDA 483 Response Patricia L. Norris, MD - Form 483R, 2017-03-01
November, 2013 FDA 483 Orchid Orthopedic Solutions Oregon, Inc. - Form 483, 2013-11-13
August, 2018 FDA 483 WCG IRB, Inc - Form 483, 2018-08-24
June, 2017 EIR James W. Baker, MD - EIR, 2017-06-19
March, 2022 FDA 483 David R. Greeley, MD - Form 483, 2022-03-25
October, 2015 FDA 483 Response Cheta Nand, M.D. - Form 483R, 2015-11-25
October, 2015 EIR Cheta Nand, M.D. - EIR, 2015-10-30
August, 2015 EIR Andrew Blauvelt, MD, MBA - EIR, 2015-08-10
May, 2016 FDA 483 James W. Baker, MD - Form 483, 2016-05-26

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.

FDA Investigator Profile Icon

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