FDA Investigator Kimberly Lewandowski Walker

Kimberly Lewandowski Walker has conducted inspections on 279 sites in 15 countries as of 30 Oct 2017. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
279
Last Inspection Date:
30 Oct 2017
Investigator Role:
FDA Investigator
Redica ID:
100002338
Countries of Inspections:
Italy, United States of America, Canada, Mexico, Switzerland, Puerto Rico, Sweden, Germany, United Kingdom of Great Britain and Northern Ireland, Belgium, Singapore, France, Netherlands, Ireland, Costa Rica
FDA Investigators that have inspected at least one site in common with Kimberly Lewandowski Walker:
Aaron L Dunbar, Adaliz Santaliz Cruz, Adam S Freeman, Aimee J Edwin, Albert L Nguyen, Alecia L Marson, Alexander M Kay, Alexandria L Capuano, Alicia M Mozzachio, Alison A Nicoli, Alison A Stone, Alla Dubrovsky, Allison M Scheck, Althea A Williams, Amanda Dinaro, Amanda S Zorn, Amir Alavi, Amy S Graf, Ana E Morales, Anderson, Andrea A Branche, Andrew A Leboeuf, Angela E Glenn, Anna Flynn, Annabelle Crusan, D,VM, Annette Melendez, Anthony L Nicoli, Anthony P Duran, Anthony R Petriella, Anya Dlockett Evans, April L Young, Arie C Menachem, Art O Czabaniuk, Arthur S Williams, Jr, Ashleigh P Barkans, Ashleigh P Wodushek, Ashley A Mutawakkil, Ashley A Segura, Babatunde D Babalola, Benjamin J Dastoli, Benjamin J Smith, Benjamin W Anderson, Bill Tacket, Jr, Billi Jom Johnson, Bleta Vuniqi, Boun M Xiong, Brenda L Reihing, Brian D Nicholson, Brian L Szcyubialka, Brian P Putz, Brittani N Franklin, Bruce H Mccullough, Bryan J Love, Burnell M Henry, Carl A Huffman, III, Carolyn E Barney, Carrie Ann Plucinski, Casey L Hamblin, Catherine J Laufmann, Catherine M Vanderhoef, CDR Sean T Creighton, Chad E Schmear, Charles D Brown, Charles L Larson, Charles M Spyr, Charles N Dupont, Chiang Syin, PhD, Christina A Castineyra, Christine I Shaw, Christine M Parmentier, Christopher B May, Christopher D Leach, Christopher D Rush, Cindy Gunnarson, Claudette D Brooks, Clifford F Long, Clifton L Randell, Constance L Richard, Corey K Reno, Coreyk Zelinski, Creighton T Tuzon, Cynthia A Harris, MD, RN, Cynthia L Aycock, Cynthia L Gorveatt, Cynthia T Cain, Daniel C Kearns, Daniel Kearns, Dannie E Rowland, David H Smith, David J Gasparovich, David J Gomes, David J Ward, Dawn M Braswell, Deborah A Greco, Deborah M Trout, Debra I Love, Debra L Curtis, Debra Lboyd Seale, Dejon N Harris, Demetria L Lueneburg, Denise L Burosh, Diane T Reindl, Dianiris C Ayala, Dolores Harper, Donald W Myrick, Donna Ltartaglino Besone, Douglas R Nelson, Douglas W Atkins, Dr. Guang Gao, PhD, Dr. Zhihao Qiu (Peter), PhD, Edward D Mcdonald, Edward E Lockwood (EEL), Edward J Janik, Elias H Wachter, Elizabeth L Holmes, Elizabeth P Mayer, Ellen C Weisensel, Ellen J Tave, Elliot P Cowam, PhD, Emily J Orban, Emma R Schaefer, Emmanuel A Dimaano, Jr, Eric A Breselow, Eric C Fox, Eric M Mueller, PharmD, Eric S Pittman, Eric W Anderson, Erin L Mcfiren, Ernest H Blackwood, Fannie M Harrell, Francis A Guidry, Francis J Eng, Gary Durbiel Goldner, Gary L Zaharek, Gene D Arcy, George G Calafactor, George T Allen, Jr, German Rivera, Gordon T Wales, Graham N Giesen, Grant L Davis, Gregson A Joseph, Hamed Ghoda, Hector Jcolon Torres, Helen B Ricalde, Howard A Burmester, Humera T Khan, Iris C Macinnes, Ivan E Reyes, J Elkins, Jaclyn N Munsch, Jacob W Reynolds, Jacqueline S Warner, James A Beaulieu, James A Lane, James D Hildreth, James D Planchon, James E Szelc, James L Dunnie, Jr, James L Finn, James M Odonnell, James P Mcreavey, James R Fleckenstein, James R Montero, James W Plucinski, Jamie R Thompson, Jan B Welch, Janet B Abt, Janet Pulver, Janis R Armedoriz, Jasjeet K Sekhon, Jason F Chancey, Jason Weaver, Javelle P Spann, Javier O Vega, Jay V Jariwala, Jean M Bosenbecker, Jeanne M Morris, Jeffery A Hangartner, Jeffrey J Thibodeau, Jeffrey R Wooley, Jeffry A Bernhardt, Jennifer Cunningham, Jennifer D Young, Jennifer Guttuso, Jennifer L Wolfe, Jennifer S Ness, Jesse A Vazquez, Jesse P Romenesko, Jessica L Barr, Jessie E Morris, Joan A Loreng, Jocelyn C Turner, Jocelyn E Massey, Jocelyn T Ramos, Joel D Hustedt, Joey V Quitania, John E Emmert, John M Mcinnis, John M Seale, Jolene S Hedgecock, Jon C Polzine, Jose Acruz Gonzalez, Jose F Pedro, Joseph A Morkunas, Joseph A Seitz, III, Joseph M Edwin, Juan A Morales, Jude C Dikes, Julie D Bringger, Justin A Boyd, Justin J Jafferis, K Gonzlez, Kaarin M Slotte, Karen Emasley Joseph, Karen M Gasperic, Karen M Labounty, Karen M Rodriguez, Kari M Johansen, Karl D Hezel, Katarzyna Plona, Katherine A Clarke Girolamo, Katherine E Jacobitz, Kathleen B Swat, Kathleen S Tormey, Kathryn M Mogen, Keith C Rindahl, Kellie L Thommes, RN, Kelvin Cheung, Kenneth A Libertoski, Kevin A Gonzalez, Kia L Copeland, Kim M Downing, Kimberly L Anderson, Kimberly M Wiegand, Kimberly W Destromp, Kinh Q Mac, Kujtim Sadiku, Laiza V Garcia, Lakisha M Williams, Laura E Garcia, Laureen M Geniusz, Lauren E Burke, Lauren E Sexton, Lauren E Skokan, Laurie A Haxel, Laurie B Frazier, LCDR Anastasia M Piliafas Brown, LCDR Michael H Tollon, LCDR Wilfred A Darang, Leo J Lagrotte, Leon R Stratman, Leonard H Lavi, Lequita M Mayhew, Liliya V Bubiy, Linda S Shook, Lisa A Warner, Lisa Hornback, Lisa M Lopez, Lisa T Michel, Lorelei S Jarrell, Lori A Carr, Lori J Silverstein, Lori S Lawless, Lorna F Jones, LT Mark A Chen, MPH, LT Rafael Gonzalez, Lydia S Chan, Maida Henesian (NMI), Marc R Dickens, Marcus F Yambot, Margaret Torres Vazquez, Maricelys Mercado, Marilyn Santiago, Marissa S Henning, Marissa S Steinhagen, Mark C Saale, Mark E Chan, Mark E Frank, Marlo Ianm Alintanahin, Martha Sullivan Myrick, Martha T Olone, Mary R Chestolowski, Matthew D Schnittker, Matthew J Sienko, Matthew M Vernon, Maureen C Melvin, Melanie W Pishnery, Melba Trivera Clavell, Melissa D Kalik, Melissa I Michurski, Melissa J Holz, Melissa J Ireland, Miaja Umaedi, Michael D Robinson, Michael E Maselli, Michael Shanks, MS, Michele L Obert, Michelle J Glembin, Minh D Phan, Mohammed H Adam, Monica Cburgos Garcia, Mra Davism, Msdap Gonzlezk, Nancy L Neiger, Nathan R Moon, Neal L Adams, Nicholas F Lyons, Nicholas R Nance, Nicholas T Domer, Nicholas Z Lu, Nicole C Shokatz, Nicole C Victoria, PhD, Nicole J Clausen, Nicole K Trudel, Nicole S Williams, Noreen Muñiz, Norman Wong, Nydia E Colon, Omotunde O Osunsanmi, Pablo Feliciano, Paola S Barnett, Patricia A Mcilroy, Patrick B Cummings, Patrick J Campbell, Paul E Stein, Paul W Moy, Peter Haase, Peter T Erlandson, Philip M Steele, PhD, Phillip M Pontikos, Prabhu P Raju, Pradip N Akolkar, Rafael A Kaup, Rafael Gonzalez Pizarro, Rafael Padilla, Ralph Jerndal, Rebecca L Caulfield, Rebecca L Mullikin, Rebecca L Stephany, Rebecca Rodriguez, Regina T Brown, Richard Jay Tucker, RS, Richard K Vogel, Richard L Rutherford, Richard M Willey, Richard W Koller, Ricki A Chase, Robert L Stevenson, Roberta W Cunningham, Rodney D Combs, Ronald Ifraimov, Ronald R Ruff, Ronald T Weber, Rosanna M Goodrich, Rostislav Servetnyk, Roy Baby, Russell K Riley, Ruth Moore, PhD, Ryan J Benedict, Samuel K Gibbons, Jr, Sandra A Hughes, Sandra D Wilson, Sara M Onyango, Sarah A Palmer, Sarah B Tanksley, Sargum C Sood, Scott A Nabe, Scott B Laufenberg, Scott K Zika, Scott L Schenian, Scott R Nichols, PhD, Seneca D Toms, Sergio Chavez (NMI), Shafiq S Ahadi, Shalonda C Clifford, Sharon L Matson, Shaun M Olson, Sherri N Rohlf, MD, Sherrie L Krolczyk, Shirley H Isbill, Shirley J Berryman, Sonya L Karsik, RAC, Stanley B Eugene, BS, BME, Stephen C Smith, Stephen D Brown, Stephen D Eich, Stephen R Souza, Steven A Skaar, Steven B Barber, Susan A Atcher, Susan A Zullo, PhD, Susan F Laska, MS, Susan M Atcher, Susan M Jackson, Susan M Matthias, Susan T Hadman, Suzanne M Crotty, Talmane J Fisher, Tamara Brey, Tania E Garcia, Tania E Vizcaino, Tara M Carolfi, Tara M Humfeld, Teresa Jimenez, Thai T Duong, That Q Dang, Theresa M Spicer, Thomas A Peter, Thomas W Garvin, Tiki J Dixon, Timothy C Grome, Timothy G Philips, Todd D Alspach, Todd M Stankewicz, Tony T Yang, Tyler R Courtney, Vickie L Anderson, Vicky L Cruz, Victor Spanioli, Wanda J Torres, William D Tingley, William P Fournier, Xiaokuang Lai, PhD, Yehualashet A Gessesse, Yvette E Guillermo, Zhong Li, PhD

Kimberly Lewandowski Walker's Documents

Publish Date Document Type Title
September, 2014 FDA 483 Lone Star Medical Products, Inc. - Form 483, 2014-09-23
November, 2013 FDA 483 Rockford Specialties - Form 483, 2013-11-12
September, 2005 FDA 483 Boston Scientific Corporation - Form 483, 2005-09-01
September, 2012 FDA 483 Abbott Medical - Form 483, 2012-09-14
December, 2013 FDA 483 Align Spine LLC - Form 483, 2013-12-04
January, 2013 FDA 483 Alma Lasers, Inc. - Form 483, 2013-01-29
December, 2008 EIR Abbott Laboratories - EIR, 2008-12-11
June, 2015 FDA 483 Cortek Endoscopy Inc - Form 483, 2015-06-16
April, 2014 FDA 483 Beta Biomed Services, Inc - Form 483, 2014-04-09
May, 2014 FDA 483 Abbott Medical - Form 483, 2014-05-16
July, 2002 FDA 483 Guy & O'Neill Inc - Form 483, 2002-07-19
March, 2010 FDA 483 Terumo Cardiovascular Systems Corporation - Form 483, 2010-03-29
December, 2015 FDA 483 Medtronic International Trading Sarl - Form 483, 2015-12-04
September, 2003 FDA 483 Shoney Scientific, Inc. - Form 483, 2003-09-19
October, 2011 FDA 483 Healthtronics, Inc. - Form 483, 2011-10-19
November, 2014 FDA 483 Ra Medical Systems, Inc. - Form 483, 2014-11-05
September, 2003 FDA 483 Medpacs Displays, Inc - Form 483, 2003-09-12
November, 2015 FDA 483 Zimmer Manufacturing B.V. - Form 483, 2015-11-17
March, 2011 FDA 483 Baxter Healthcare Renal Div - Form 483, 2011-03-29
August, 2002 EIR Grande Cheese Company - EIR, 2002-08-15
September, 2009 FDA 483 Northeast Resins & Silicones, LLC - Form 483, 2009-09-10
June, 2009 FDA 483 Avinger Inc. - Form 483, 2009-06-11
August, 2010 EIR Abbott Medical - EIR, 2010-08-25
July, 2005 FDA 483 Immucor GTI Diagnostics, Inc - Form 483, 2005-07-20
December, 2013 FDA 483 Smart Medical Technology Inc - Form 483, 2013-12-17
May, 2009 FDA 483 Stryker Instruments Div. of Stryker Corporation - Form 483, 2009-05-14
May, 2013 FDA 483 Ciba Vision Corporation - Form 483, 2013-05-09
September, 2003 FDA 483 Response Medpacs Displays, Inc - Form 483R, 2003-10-31
August, 2010 FDA 483 Abbott Medical - Form 483, 2010-08-25
May, 2012 FDA 483 Stericycle Inc - Form 483, 2012-05-22
June, 2009 FDA 483 Siemens Medical Solutions USA, Inc - Form 483, 2009-06-09
August, 2013 FDA 483 Sirtex Singapore Manufacturing Pte Ltd - Form 483, 2013-08-15
September, 2012 EIR Abbott Medical - EIR, 2012-09-14
June, 2013 FDA 483 7 Mile Solutions Inc., dba Maxant Technologies - Form 483, 2013-06-25
November, 2003 FDA 483 Merge Healthcare, Inc. - Form 483, 2003-11-19
September, 2015 FDA 483 IOS Technologies Inc - Form 483, 2015-09-02
January, 2013 EIR Alma Lasers, Inc. - EIR, 2013-01-29
October, 2013 FDA 483 M D Technologies, Inc. - Form 483, 2013-10-24
February, 2014 FDA 483 Terumo Cardiovascular Systems Corporation - Form 483, 2014-02-17
June, 2015 FDA 483 Rondex Products, Inc. - Form 483, 2015-06-02
September, 2003 EIR Medpacs Displays, Inc - EIR, 2003-09-12
May, 2009 FDA 483 Response Stryker Instruments Div. of Stryker Corporation - Form 483R, 2009-06-16
May, 2009 FDA 483 Response Stryker Medical Division of Stryker Corporation - Form 483R, 2009-06-12
February, 2012 FDA 483 Cypress Medical Products LLC - Form 483, 2012-02-08
May, 2014 EIR Abbott Medical - EIR, 2014-05-16
September, 2005 FDA 483 Response Boston Scientific Corporation - Form 483R, 2005-09-15
March, 2017 FDA 483 Oscor Inc. - Form 483, 2017-03-23
May, 2009 FDA 483 Stryker Medical Division of Stryker Corporation - Form 483, 2009-05-15
May, 2005 EIR Life Technologies Corporation - EIR, 2005-05-19
April, 2016 EIR Roche Diagnostics GmbH - EIR, 2016-04-14
August, 2003 FDA 483 Welch Allyn Inc (Baxter affiliate) - Form 483, 2003-08-28
August, 2013 FDA 483 MP Biomedicals Asia Pacific Ptd Ltd - Form 483, 2013-08-22
April, 2016 FDA 483 Roche Diagnostics GmbH - Form 483, 2016-04-14
October, 2014 FDA 483 Vyaire Medical, Inc. - Form 483, 2014-10-31
May, 2011 FDA 483 Medtronic Puerto Rico Operations Co. - Form 483, 2011-05-11
December, 2002 FDA 483 Frontier Medical Products Inc. - Form 483, 2002-12-11
August, 2010 FDA 483 Response Abbott Medical - Form 483R, 2010-09-15
September, 2003 FDA 483 Immucor GTI Diagnostics, Inc - Form 483, 2003-09-09
September, 2009 FDA 483 Bioresource Technology Inc - Form 483, 2009-09-03
May, 2011 EIR Medtronic Puerto Rico Operations Co. - EIR, 2011-05-11
November, 2015 EIR Zimmer Manufacturing B.V. - EIR, 2015-11-17
June, 2015 FDA 483 Forte Automation Systems Inc - Form 483, 2015-06-10
March, 2014 FDA 483 AMO Puerto Rico Manufacturing, Inc. - Form 483, 2014-03-26

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