FDA Investigator Melanie W Pishnery

Melanie W Pishnery has conducted inspections on 160 sites in 23 countries as of 10 Jun 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
160
Last Inspection Date:
10 Jun 2024
Investigator Role:
FDA Investigator
Redica ID:
100003447
Countries of Inspections:
Japan, Germany, United States of America, France, Canada, United Kingdom of Great Britain and Northern Ireland, Sweden, Hungary, China, Austria, Ireland, Portugal, Denmark, Taiwan, Italy, Korea (Republic of), Belgium, Finland, Israel, Switzerland, Poland, Vietnam
FDA Investigators that have inspected at least one site in common with Melanie W Pishnery:
Aaron J Fox, Adaliz Santaliz Cruz, Aigbokhai A Dirisu, Akbar J Zaidi, Althea A Williams, Amanda S Zorn, Ana L Kewes, Andrea A Branche, April R Bowen, Ashar P Parikh, Ashleigh P Barkans, Ashleigh P Wodushek, Ashley A Mutawakkil, Ashley A Segura, Babatunde D Babalola, Barbara M Frazier, Barbara T Carmichael, Bill Tacket, Jr, Billi Jom Johnson, Brentley S Collins, Brittny C Cargo, Byungja E Marciante, Calvin K Cook, Carol S Davis, Carolyn E Barney, Catherine J Laufmann, CDR Ileana Barreto Pettit, CDR Sean T Creighton, CDR Thomas R Berry, PPh, Chad E Schmear, Charles J Chacko, Chateryl K Washington, Cheryl D Mccall, Christie A Soto, Christine I Shaw, Christine M Humphrey, Christine M Parmentier, Christopher B May, Christopher C Wilcox, Christopher D Leach, Christos G Tsingelis, Clara E Santiago, Claudette D Brooks, Cordelia J Brammer, Courtney A Gilbert, Daniel J Lahar, Darcy E Brillhart, Daryl A Dewoskin, David E Lowe, David M Beltran, David M Wilkinson, David P King, Dawn M Braswell, Dellarese L Herbert, Dennis R Hock, Derek C Price, Dillard H Woody, Jr, Djamila Harouaka, Dolores Harper, Donna Ltartaglino Besone, Edward D Mcdonald, Edward E Lockwood (EEL), Elizabeth D Connell, Emma R Schaefer, Eric M Padgett, Eric W Anderson, Erin L Mcfiren, Ernest A Clausnitzer, Ernest H Blackwood, Frank J Marciniak, Fulton A Varner, Gamal A Norton, Gene R Gunn, George T Allen, Jr, Gerardo Z Vazquez, Gisselle I Sensebe, Gregson A Joseph, Harshal J Desai, Heather Akleimola Hulbert, Helen R Bester, Ibad U Khan, Inga M Warr, Ingrid A Zambrana, Jacqueline S Warner, James D Planchon, James P Mcreavey, James W Whitney, Jamie P Webb, Jana L Caylor, Janete F Guardia, Jason P Aun, Javelle P Spann, Jawaid Hamid, Jennifer A Robinson, Jennifer Lalama, Jennifer M Gogley, Jennifer S Ness, Jesse A Vazquez, Jessica L Pressley, Joan A Loreng, Joanne E King, Joe A Odom, Jolanna A Norton, Jose A Lopez, Joseph M Edwin, Joseph T Goertz Jr, Joshua J Silvestri, Juanj N Wu, Karen A Coleman, Karen Emasley Joseph, Karen L Anderson, Karen M Rodriguez, Katelyn Astaub Zamperini, Kathleen B Swat, Kellia N Hicks, Kelvin Cheung, Kim M Downing, Kimberly Cdelk Brooks, Kimberly Lewandowski Walker, Kinh Q Mac, Ladislav Kermet, Laiza V Garcia, Laura E Garcia, Laura L Staples, LCDR Matthew J Morrison, LCDR Michael H Tollon, Leo J Lagrotte, Leonard H Lavi, Leslie W Gilbert, Liliane Brown, Linda K Matheny, Linda K Weir, Lisa A Warner, Lori A Carr, LT Daveta L Bailey, Maida Henesian (NMI), Marc S Neubauer, Marcellinus D Dordunoo, Marian E Ramirez, Maribeth G Niesen, Marissa S Steinhagen, Mark E Chan, Marvin A Marenco, Mary A Millner, Mary L Schuckmann, Maryam Tabatabaie, Matthew A Humbard, Matthew T Sanchez, Melanie G Warzala, Melinda B Lewis, Mercedes B Mota, Miaja Umaedi, Michael D Gifford, Michelle D Haamid, Michelle J Glembin, Miguel A Martinez Perez, Minh D Phan, Mizanne E Lewis, Monica Cburgos Garcia, Myla D Chapman, Myoshi M Francis, Nicholas Z Lu, Nicolas Riveratorres, Nicole E Knowlton, Nicole K Buck, Nikki S Bryant, Omotunde O Osunsanmi, Patricia A Mcilroy, Patricia F Hudson, Paul A Bonneau, Paul L Figarole, Jr, Paul W Moy, Phillip M Pontikos, Prabhu P Raju, Quynh H Strandberg, Rafael Padilla, Ralph Jerndal, Richard Jay Tucker, RS, Richard K Vogel, Richard L Rutherford, Robert D Tollefsen, Robert G Ruff, Robert Jennings, Rodney B Ross, Ronald Ifraimov, Ronald T Weber, Rosanna M Goodrich, Saeid E Kazan, Salvatore N Randazzo, Samantha J Pinizzotto, D V M, Samuel L Murray, Sarah A Hassas, Sarah E Mcmullen, Sarah Forney, Sargum C Sood, Saundrea A Munroe, Sayeeda Hdabe, Seneca D Toms, Shafiq S Ahadi, Shari H Shambaugh, Shayla G Turnipseed, Stanley B Eugene, BS, BME, Stephanie D Crockett, Stephanie E Hubbard, Stephanie Harrell, Stephen D Eich, Stephen R Souza, Steven A Brettler, Suzanne M Healy, Suzanne N Vallez, Tamara M Casselman, Tania E Vizcaino, Terry C Kimball, Thai T Duong, Thomas A Peter, Timothy G Philips, Traci M Armand, Tracy L Reed, Trang N Cox, Vanessa E Coulter, Virginia Carroll, PhD, Virginia L Meeks, Wanda B Coats, Wanda J Torres, Wayne E Seifert, William D Tingley, Yehualashet A Gessesse, Yung W Chan, Yvette Mlacour Davis

Melanie W Pishnery's Documents

Publish Date Document Type Title
October, 2013 FDA 483 The Lifestyle GP Company, LLC - Form 483, 2013-10-31
February, 2015 FDA 483 Response Stat Medical Devices, Inc. - Form 483R, 2015-03-12
September, 2017 FDA 483 Circuit Works Corporation - Form 483, 2017-09-14
April, 2016 FDA 483 C.R. BARD, INC. - Form 483, 2016-04-19
November, 2017 FDA 483 Illes Csok Es Tarsa Kft - Form 483, 2017-11-02
April, 2017 FDA 483 bioMerieux, Inc. - Form 483, 2017-04-10
June, 2023 FDA 483 Techlem Medical Corporation - Form 483, 2023-06-22
June, 2013 FDA 483 Novalis Medical, LLC - Form 483, 2013-06-12
October, 2018 FDA 483 Greiner Bio-One GmbH - Form 483, 2018-10-25
May, 2013 FDA 483 Gulf Fiberoptics, Inc. - Form 483, 2013-05-06
December, 2013 FDA 483 SmartScience Laboratories, Inc. - Form 483, 2013-12-06
February, 2013 FDA 483 Stellar Medical LLC. - Form 483, 2013-02-14
March, 2019 FDA 483 BD Life Sciences, Preanalytical Solutions - Form 483, 2019-03-01
September, 2021 FDA 483 Sky Medical Supplies and Equipments, LLC - Form 483, 2021-09-17
October, 2018 FDA 483 Avanos Medical, Inc. - Form 483, 2018-10-02
August, 2015 EIR Synergy Health North America - EIR, 2015-08-26
May, 2022 FDA 483 The See Clear Company - Form 483, 2022-05-24
September, 2015 FDA 483 American Contract Systems, Inc. - Form 483, 2015-09-04
February, 2018 FDA 483 Response Syncro Medical Innovations, Inc. - Form 483R, 2018-03-14
February, 2018 FDA 483 Syncro Medical Innovations, Inc. - Form 483, 2018-02-22
March, 2023 FDA 483 TERUMO CORPORATION - Form 483, 2023-03-21
February, 2018 EIR Syncro Medical Innovations, Inc. - EIR, 2018-02-22
November, 2015 FDA 483 Isolux, LLC - Form 483, 2015-11-06
June, 2013 FDA 483 Biolife, LLC - Form 483, 2013-06-28
April, 2019 FDA 483 Kids II, Inc - Form 483, 2019-04-18
October, 2018 EIR Greiner Bio-One GmbH - EIR, 2018-10-25
July, 2021 FDA 483 Teleflex LLC (NADC) - Form 483, 2021-07-30
July, 2016 FDA 483 Abbott Laboratories, Inc. - Form 483, 2016-07-28
November, 2022 FDA 483 Surgical Instruments Belgium SA (SIBEL S.A.) - Form 483, 2022-11-10
January, 2015 FDA 483 Soft Computer Consultants, Inc. - Form 483, 2015-01-15
April, 2022 FDA 483 Elite-Medical, LLC - Form 483, 2022-04-29
July, 2016 FDA 483 Response Abbott Laboratories, Inc. - Form 483R, 2016-08-18
June, 2015 FDA 483 TRACOE Medical GmbH - Form 483, 2015-06-18
March, 2023 FDA 483 TERUMO YAMAGUCHI CORPORATION - Form 483, 2023-03-30
October, 2021 EIR Greiner Bio-One North America, Inc. - EIR, 2021-10-29
October, 2021 FDA 483 Greiner Bio-One North America, Inc. - Form 483, 2021-10-29
December, 2016 EIR Stradis Medical, LLC dba Stradis Healthcare - EIR, 2016-12-19
March, 2019 FDA 483 Innomed, Inc. - Form 483, 2019-03-21
March, 2022 FDA 483 Pajunk Medical Systems, L.P. - Form 483, 2022-03-18
August, 2019 FDA 483 Cancer Diagnostics Inc. - Form 483, 2019-08-14
March, 2015 FDA 483 Ascom (US) Inc. - Form 483, 2015-03-27
March, 2019 FDA 483 Enuresis Solutions, LLC - Form 483, 2019-03-26
February, 2015 EIR Stat Medical Devices, Inc. - EIR, 2015-02-20
October, 2018 EIR Avanos Medical, Inc. - EIR, 2018-10-02
August, 2013 FDA 483 Parcus Medical, LLC - Form 483, 2013-08-16
November, 2023 FDA 483 Tianjin Medis Medical Device Co., LTD. - Form 483, 2023-11-16

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