FDA Investigator Michele Gottshall

Michele Gottshall has conducted inspections on 36 sites in 6 countries as of 20 May 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
36
Last Inspection Date:
20 May 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, Japan, India, Canada, Taiwan, Australia
FDA Investigators that have inspected at least one site in common with Michele Gottshall:
Ademola O Daramola, Alan D Centi, Amy A Johnson, Amy M Cramer, Anastasia I Offordile, Anastasia M Shields, Anita R Michael, Ann L Demarco, Ann Marie Karnick, Ariel Cruz Figueroa, Audrey Thereset Uy, Bijoy Panicker, Brandi L Garbutt, Brandon J Brookens, Brandy N Lepage, Brian S Keefer, Calvin W Edwards, Cara M Minelli, Carolyn E Barney, Catherine J Laufmann, Christina K Theodorou, Christopher T Middendorf, Cody D Rickman, Colleen M Damon, Crystal A Harlan, Cynthia A Palmer, Cynthia White, Daniel J Grabicki, David A Oluwo, David J Hafner, David L Pearce, Dawn M Braswell, Deborah B Nixon, Debra I Love, Debra L Pagano, Denise M Digiulio, Devon Jenkins, Douglas C Kovacs, Edward D Mcdonald, Emily A Walters, Erika M Wilkerson, Erin D Mccaffery, Frank J Marciniak, Frank Wackes, Gayle S Lawson, George J Flynn, George Pyramides, Gerald W Kopp, Geraldine D Sanders, Guerlain Ulysse, Hala L Selby, Hala Lj Whetstone, Harry J Brewer, Helen B Ricalde, Helen Verdel, Jacqueline Mdiaz Albertini, Jai P Singh, Jaison J Eapen, James L Dunnie, Jr, James L Finn, James M Mason, Janet L Bowen, Jeen S Min, Jennifer A Bazergui, Jennifer L Custodio, Jennifer Macmillan, Joel D Hustedt, Jose M Cayuela, Joseph T Dougherty, Julianne C Mccullough, Junho Pak, Karen A Briggs, Karen E D'orazio, Karyn M Campbell, Katherine Szestypalow, Kazi Rafiquzzaman, Kendra L Brooks, Kenneth H Williams, Kevin A Gonzalez, Kevin Obrien, Kham Phommachanh, Kim Lthomas Cruse, Kimberly A Dux, Kip J Hanks, Kish Bolden, Ko U Min, Kristen D Evans, Kristina J Donohue, Kristina Mjoyce Pittman, Kristy A Zielny, Kshitij A Patkar, Lance Mde Souza, MBA, Latorie S Jones, LCDR Margaret Edi Gennaro, LCDR Michael H Tollon, LCDR Susan E Polifko, Li Li, Liatte Kreuger, PharmD, Linda M Hoover, Linda Thai, Lisa Harlan, Lisa M Bellows, LTJG Bradley E Benasutti, Margaret L Bolte, Marie A Fadden, Matthew R Noonan, Maureen A Wentzel, Meena Bansal Gupta, PhD, Mei Chiung Huang (Jo), Melba Trivera Clavell, Melissa M Dauksis, Melissa M Schafer, Melissa T Roy, Michael A Charles, Michael Gurbarg, Michael R Goga, Michael R Klapal, Michele M Falchek, Monika Borkowska, Nadeem I Chaudhry, Nadia R Barreda, Nancy F Scheraga, Nancy M Espinal, Nicholas A Violand, Niketa Patel, Nikisha M Bolden, Omotunde O Osunsanmi, Parul M Patel, Patricia A Cochran, Patricia H Dlugosz, Patrick C Klotzbuecher, Patty P Kaewussdangkul, Paul L Bellamy, Prabhu P Raju, Pratik S Upadhyay, DDC, Rabin N Ghoshal, Raffi B Papazian, Reba A Gates, Regina T Brown, Robert C Coleman, Robert C Steyert, Robert J Maffei, S Lori Brown, PhD MPH, Saleem A Akhtar, Sam Pepe, Sangeeta M Khurana, PhD, Sarah Forney, Satheesh Thomas, Seng Ching Hwang, Sharon K Thoma, PharmD, Simone E Pitts, Stephanie Mangigian, MS/OSH, RN, Stephen D Brown, Stephen J Koniers, Steven E Kane, Steven Frisbee, Steven P Donald, Susan F Laska, MS, Susan O Oladeji, Tara G Bizjak, Tara R Gooen, Theresa Kirkham (NMI), Thomas E Friel, Thomas J Arista, Thomas N Adjabeng, Tiffani D Wilson, Tina M Pawlowski, Todd J Maushart, Tracy K Li, Truong Xuan Nguyen (Andy), Vlada Matusovsky, Wayne D Mcgrath, Whitney S Reynolds, Yumi J Hiramine, Yvesna C Blaise

Michele Gottshall's Documents

Publish Date Document Type Title
September, 2022 EIR Fragrance Manufacturing, Inc. - EIR, 2022-09-14
November, 2023 FDA 483 HAMARI PFST, Ltd. - Form 483, 2023-11-10
February, 2022 FDA 483 Almac Pharma Services LLC - Form 483, 2022-02-03
February, 2022 EIR Almac Pharma Services LLC - EIR, 2022-02-03
March, 2020 FDA 483 KVK-TECH, INC - Form 483, 2020-03-13
November, 2022 FDA 483 Royal Chemical Company, Ltd. - Form 483, 2022-11-08
August, 2022 FDA 483 SPRAY-TEK, INC. - Form 483, 2022-08-17
February, 2023 FDA 483 Patheon Inc. - Form 483, 2023-02-17
February, 2023 FDA 483 Patheon Inc. - Form 483, 2023-02-24
October, 2021 FDA 483 Princeton Analytical Laboratories - Form 483, 2021-10-07
June, 2021 FDA 483 KVK-TECH, INC - Form 483, 2021-06-11
September, 2022 FDA 483 Fragrance Manufacturing, Inc. - Form 483, 2022-09-14
June, 2022 FDA 483 GENERICHEM CORPORATION - Form 483, 2022-06-08
January, 2024 FDA 483 Henkel US Operations Corporation - Form 483, 2024-01-18
October, 2023 FDA 483 Astellas Pharma Inc. - Form 483, 2023-10-27
April, 2022 FDA 483 Circadia by Dr Pugliese, Inc. - Form 483, 2022-04-01
March, 2021 FDA 483 Johnson & Johnson Consumer, Inc - Form 483, 2021-03-24
September, 2022 FDA 483 Response Fragrance Manufacturing, Inc. - Form 483R, 2022-10-04
March, 2023 FDA 483 BWXT Medical Ltd. - Form 483, 2023-03-03
May, 2024 FDA 483 American CryoStem Corporation - Form 483, 2024-05-22
February, 2023 EIR Patheon Inc. - EIR, 2023-03-29
February, 2023 EIR Patheon Inc. - EIR, 2023-03-27

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

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