FDA Investigator Wayne E Seifert

Wayne E Seifert has conducted inspections on 63 sites in 16 countries as of 30 May 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
63
Last Inspection Date:
30 May 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Ireland, United States of America, United Kingdom of Great Britain and Northern Ireland, Malaysia, Korea (Republic of), Italy, Belgium, France, Germany, Switzerland, Spain, Austria, Denmark, India, Japan, Netherlands
FDA Investigators that have inspected at least one site in common with Wayne E Seifert:
Aaron L Dunbar, Adam R Cooke, Ademola O Daramola, Aditi S Thakur, Aimee Cunningham, PhD, Alan L Truong, Alan R Condon, Albert A Salvador, Alberto A Viciedo, Alice S Tsao, Alicia M Mozzachio, Amber D Brodas, Amy C Jordan, Amy Devlin, PhD, Amy N Chen, Anastasia G Lolas, Anastasia M Shields, Anders W Evenson, Andrace L Deyampert, Andrea A Branche, Andrea D Swingle, Andrea Siegel, PhD, Andrew "Drew" Haack, PhD, Andrew J Barrowcliff, Andrew K Haack, PhD, Andrew M Barlow, Anh M Lac, Anissa M Cheung, Anita Narula, PhD, Anjali Shukla, PhD, Ann L Demarco, Ann Marie Montemurro, Antonina Aydanian, Arie C Menachem, Arsen Karapetyan, Arulvathani P Arudchandran, Ashar P Parikh, Ashley N Queen, PhD, Azza Talaat, Baolin Zhang, PhD, Barbara Janine Breithaupt, Bei Y He, Ben Du, Benjamin J Smith, Bijoy Panicker, Bo Chi, PhD, Bonita S Chester, Brandon C Heitmeier, Brandy N Lepage, Brenda P King, Brenda W Uratani, PhD, Brentley S Collins, Brian D Nicholson, Brian M Janelsins, PhD, Brittani N Franklin, Brooke K Higgins, Bruce H Mccullough, Burnell M Henry, Byungja E Marciante, Calvin B Koerner, Camerson E Moore, Candace Y Gomez Broughton, Carl A Huffman, III, Carla A Norris, Carla J Lundi, Carolyn A Renshaw, Carrie Ann Plucinski, Cary Greene, Caryn M Mcnab, Catherine J Laufmann, CDR Donald Ertel, CDR Rochelle B Young, RPh, MSA, CDR Thomas R Berry, PPh, Charisse K Green, Charles I Ann, Charles Jewell, Charles L Zhou, Charles Yuanchia Kuo, PhD, Chava Kimchi Sarfaty, PhD, Chen Sun, PhD, Chiang Syin, PhD, Chikako Torigoe, PhD, Christian D Lynch (CDL), Christina A Miller, Christina Capacci Daniel, PhD, Christina K Theodorou, Christina Theodorou, Christine W Twohy, Christopher D Leach, Christopher Downey, PhD, Christopher R Czajka, Colleen F Hoyt, Concepcion Cruz, Jr, Constantin Y Philopoulos, Corrine M Carter, Craig A Garmendia, Craig D Zagata, Cristina Ausin Moreno, PhD, Cynthia J Lee, MS, Cynthia Jim, CSO, Cynthia M Goudeau, Cynthia White, Daniel B Arrecis, Daniel J Lahar, Daniel L Zheng, Daniel T Lee, Dariusz Galezowski, Daryl A Dewoskin, David A Paterson, David G Eng, David M Beltran, Dawn L Wydner, Dawn M Braswell, Debara R Reese, Debara Reese, Deborah M Trout, Deborah Schmiel, PhD, Debra L Pagano, Demitria J Argiropoulos, Demitria J Xiradakis, Denise L Burosh, Dennis Cantellops Paite, Dennis E Guilfoyle, PhD, Devaughn Edwards, Diane L Raccasi, Dianne S Alexander, Dien N Nguyen, Dina A Tallman, Djamila Harouaka, Doan T Nguyen, PharmD, Dogbeda F Mackenzie, Dolores Harper, Don H Bark, PhD, Donald C Obenhuber, PhD, Donna A Katz, Dorothy W Lee, Douglas A Campbell, Douglas C Kovacs, Dr. Jun Liu, PhD, Dr. Ralph M Bernstein, PhD, Dr. Robert C Horan, MD, Dr. Willie Wilson, PhD, Dr. Zhihao Qiu (Peter), PhD, Eboni S Funderburk, Edmund F Mrak, Jr, Edwin Jao, Edwin Melendez, Eileen A Liu, Ekaterina Allen, Eliezar Ramos, Ellen P Madigan, Emest F Bizjak, Emilie E Kahn, Emily J Orban, Emine Guvenmaiorov, Ephrem Hunde, PhD, Erika M Wilkerson, Erika V Butler, Erin D Mccaffery, Erin L Mcfiren, Esther C Broner, PhD, Felix Maldonado, Francis A Guidry, Frank Wackes, Freyja V Lynn, Gayle S Lawson, Gene D Arcy, George Pyramides, George T Allen, Jr, Gerald B Seaborn, Jr, Gilbert T Salud, Gloria E Parra, Guerlain Ulysse, Gunther Boekhoudt, PhD, Gwyn G Dickinson, Hai Lient Phung, Hala L Selby, Haley H Seymour, Hamet M Toure, PharmD MPH, Hao Kiet D Phan, Haoheng Yan, PhD, Helen B Ricalde, Holly Brevig, Howard Anderson, PhD, Hyung Yul Lee, Ibad U Khan, J Paul Kirwan, PhD, Jacek Cieslak, PhD, Jacob G Lutz, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James A Lane, James C Maclaughlin, James D Bridges, James I Giefer, James L Dunnie, Jr, James R Evans, James W Whitney, Jason F Chancey, Javier E Santos, Jawaid Hamid, Jay T Wong, Jean Blackston Hill, Jee Chung, PhD, Jeffrey A Sommers, Jeffrey D Meng, Jeffrey P Raimondi, Jennifer A Kemp, Jennifer C Adams, Jennifer C Johnson, Jennifer L Bridgewater, Jennifer M Gogley, Jennifer Swisher, PhD, Jens Fricke, Jeremy W Rotton, Jessica Chery, Jessica Hankins, PhD, Jianming Li, Jie He, Jing Fang, Joan A Loreng, Joan Johnson, Joey V Quitania, John D White, John P Mistler, John S Hartford, Jon P Antoniou, Jonathan G Matrisciano, Jonathan G Swoboda, Jonathan W Chapman, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose M Melendez, Jose Ohernandez Guzman, Jose R Hernandez, Joseph A Piechocki, Joseph F Owens, Joseph Kutze, PhD, Joseph R Strelnik, Joslyn K Brunelle, PhD, Joyce A Rockwell, Julianne C Mccullough, Julie D Bringger, Junho Pak, Justin A Boyd, Justine M Corson, Kalavati Suvarna, PhD, Kara A Scheibner, PhD, Karen A Briggs, Karen L Kosar, Karen M Montgomery (KMM), Karishma G Gopaul, Katherine D Adams, Katherine E Jacobitz, Katherine Szestypalow, Kathleen M Jordan, Kathleen R Jones, PhD, Kathryn E King, Kathy E Craven, Kathy E Noe, Kent C Faul, Kevin A Gonzalez, Kevin D Kallander, Kevin P Foley, Kham Phommachanh, Kim Lthomas Cruse, Kirsten L Vadheim, PhD, Ko U Min, Kristin M Abaonza, Kristina L Conroy, Kshitij A Patkar, Kula N Jha, Kumar G Janoria, Kurt A Brorson, PhD, L Norwood, L'oreal F Walker, Lakshmi Narasimhan, PhD, Lane V Christensen, PhD, Larry K Austin, Lata C Mathew, PhD, Latoya A Griffith, Laura Fontan, MS, Laura I Salazar, PhD, Laurel A Beer, Lauren Iacono Connors, PhD, Laurie Graham, Laurimer Kuilan Torres, Lawrence J Stringer, LCDR Chad N Thompson, LCDR Debra Emerson, LCDR Mark A Jimenez, RN, LCDR Sean Byrd, Lei Zhang, PhD, Leigh Anne Myers, Leiyun Boone, PhD, Leon L Law, Lewis K Antwi, Li Lu, PhD, Linda F Murphy, Linda M Cheny, Linda Thai, Lindsey Brown, PhD, Lisa B Orr, Lisa K Capron, Lisa M Bellows, Lixia Cai, Logan T Williams, Lois K Gross, Lori A Holmquist, Lori Peters, Lorie S Hannappel, LTJG Bradley E Benasutti, Lucila B Nwatu, Luella J Rossi, Luis Mburgos Medero, Lydia S Chan, Lynda L Perry, PhD, M Pedgen, Maan S Abduldayem, Madushini Dharmasena, PhD, Maida Henesian (NMI), Maotang Zhou, PhD, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marcus A Ray, Marcus F Yambot, Margaret E Sarles, Margaret M Annes, Margarita Santiago, Maria Cecilia Tami, PhD, Maria Cruz Fisher, Maria Gutierrez Hoffman, PhD, Maria Gutierrez Lugo, PhD, Maria Joselopez Barragan, PhD, Marie B Buen Bigornia, Marie F Morin, Marion Michaelis, Marisa E Stock, Mariza M Jafary, Marjorie A Shapiro, PhD, Mark Brunswick, PhD, Mark C Saale, Mark R Mcclain, Marlene G Swider, Marsha W Major, Martha Sullivan Myrick, Martha T Olone, Martin R Vowell, Mary Davis Lopez, Mary E Farbman, PhD, Mary E Storch, Mary Jeanet Mcgarry, Maryam Tabatabaie, Massoud Motamed, Mate Tolnay, Matthew A Spataro, Matthew B Casale, Maxwell Van Tassell, PhD, Maya M Davis, Megan A Haggerty, Mei Chiung Huang (Jo), Meisha R Sampson, Meisha Waters, Melanie W Pishnery, Melina Lrodriguez Upton, Melissa D Ray, Mercy Oyugi, Michael A Charles, Michael D Omeara, Michael E Maselli, Michael L Chasey, Michael P Anthony, Michael R Goga, Michael R Klapal, Michael S Araneta, Michael Shanks, MS, Michele L Forster, PhD, Michele L Glendenning, Michele L Obert, Michele Perry Williams, Michelle M Noe Varga, Michelle Yclark Stuart, Mihaly S Ligmond, Mikhail V Ovanesov, PhD, Milan S Blake, Milos Dokmanovic, PhD, Milva E Melendez Perales, Mindy M Chou, Mizanne E Lewis, Monica Commerford, PhD, Monica Markovski, PhD, Monique C Lo, Montgomery Montgomery, Karen M, Mra B Kamberem, Mra Davism, Mra Mcculloughj, Mra Munizn, Mra V Millarw, Muna Algharibeh, Murthy Vkn Sikha, Myra K Casey, Nailing Zhang, Nancy A Bellamy, Nancy L Rolli, Nancy T Waites, Nataniel Phillips Sylvain, PhD, Neali H Lucas, Nealie C Newberger, Nebil A Oumer, Nicholas F Lyons, Nicholas L Paulin, Nicole A Lloyd, Nicole K Trudel, Niketa Patel, Noreen Muñiz, Obinna R Echeozo, Ogechi C Nna, Olumide A Martins, Omotunde O Osunsanmi, Pablo Alcantara, Pankaj H Amin, Paraluman S Leonin, Parul M Patel, Patricia A Cochran, Patricia D Stahnke, Patricia F Hughes, PhD, Patricia H Dlugosz, Patrick B Cummings, Patrick C Klotzbuecher, Patrick J Lynch, Patrick L Wisor, Patsy J Domingo, Patty P Kaewussdangkul, Paul A Bonneau, Paul L Bellamy, Paul L Figarole, Jr, Paul M Kawamoto, Paul Mouris, Paula A Trost, Peng Zhou, Perry T Nichols, Pete Amin (Pankaj), Peter Adams, PhD, Peter R Lenahan, Philip F Istafanos, DMV, MS, Phillip Angart, PhD, Prabhu P Raju, Prajakta A Varadkar, Priscilla M Pastrana, Qiao Y Bobo, Qin Xu, Qing Joanna Zhou, PhD, Rabia Ballica, PhD, Rachael O Oyewole, Rafael Padilla, Rafeeq A Habeeb, Rajiv R Srivastava, Ralph A Erickson, Ralph H Vocque, Ram Sihag, PhD, Ramon E Martinez, Randy L Self, Ranjani Prabhakara, Raquel Gonzalez Rivera, Rashmi Rawat, PhD, Raymond T Oji, Rebecca E Dombrowski, Rebecca Rodriguez, Regina T Brown, Reginald D Neal, Reyes Candau Chacon, PhD, Richard H Penta, Richard Ledwidge (nmi), PhD, Richard W Berning, Richard W Thornton, Riley C Myers, PhD, Robert Barbosa, Robert C Coleman, Robert C Steyert, Robert D Tollefsen, Robert J Ham, Robert J Maffei, Robert J Martin, Robert Jennings, Robert L Stevenson, Robert M Barbosa, Roger F Zabinski, Rong Guo, Rory K Geyer, Rose Ashley, Roshni J Patel, Roy R Rinc, Rumany C Penn, PharmD, Russell J Glapion, Russell K Riley, Ruth Moore, PhD, S Lori Brown, PhD MPH, Saleem A Akhtar, Samantha J Bradley, Samina S Khan, Samuel J Arsenault, Samuel Mindaye, Sandra A Boyd, Sang Bong Lee, Sangeeta M Khurana, PhD, Santos E Camara, Sarah Arden, Sarah B Tanksley, Sarah Forney, Sarah Kennett, PhD, Sarah Nwandiuko, Sargum C Sood, Satheesh Thomas, Scott C Lute, Scott E Norris, Scott N Lim, Scott R Nichols, PhD, Scott T Ballard, Sean R Marcsisin, Sena G Dissmeyer, Seneca D Toms, Seth A Mailhot, Shana L Williams, Shannon A Gregory, Sharon K Thoma, PharmD, Shawn E Larson, Shawn R Gould, Shirley J Berryman, Sidney B Priesmeyer, Simone E Pitts, Sneha S Patel, Sony Mathews, Stacey S Degarmo, Stefanie L Heckman, Stefanie L Kremer, Stephanie A Slater, MS, Stephen D Brown, Stephen D Eich, Stephen R Souza, Steven A Gonzales, Steven B Hertz, Steven C Madzo, Steven Fong, MS, PhD, Steven Kozlowski, MD, Steven L Carter, Steven M Weinman, Steven P Donald, Stuart W Russell, Susan F Laska, MS, Susan M Jackson, Susan P Bruederle, Susan T Hadman, Susan W Ciani, Susanna E Ford, Susanne M Richardson, MS RAC, Suyang Qin, Svetlana A Shestopal, Tamara L Ely, Tamara M Casselman, Tamil Arasu, PhD, Tania E Vizcaino, Tara L Greene, Tara R Gooen, Tawny L Colling, Teegan Dellibovi Ragheb, PhD, Temar Q Williams, Terri L Dodds, Thai D Truong, Thomas A Peter, Thomas J Arista, Thomas R Withers, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Timothy J Schmidt, Tina M Pawlowski, Tina S Roecklein, Tonnie L Carter, Torrance J Slayton, Tracey L Harris, Travis S Bradley, Truong Xuan Nguyen (Andy), Tzanko Stantchev, Uduak M Inokon, Unnee Ranjan, V Teres Speer, Vaishali J Patel, Vanessa Y Gelsey, PhD, Vanessa Y Jacobs, Veronica Fuentes, MS, Victor J Gangi, Vidya B Pai, Vijaya L Simhadri, Vilmary Negron Rodriguez, Virgilio F Pacio, CSO, Virginia Carroll, PhD, Viviana Matta, Vlada Matusovsky, Walter N Lange, Wayne T Smith, Wendy G Tan, PhD, William D Tingley, William Hallett, PhD, Xianghong Jing (Emily), PhD, Xiaokuang Lai, PhD, Xiaoping Guan, Xu Michael Di, PhD, Yan Wang, Yangmin Ning, Yanming An, PhD, Yasamin Ameri, Yehualashet A Gessesse, Yetao Jin, PhD, Yideng Liang, Ying Xin Fan, PhD, Yiwei Li, Yongmin Liu, Youmin Wang, Yuan Chia Kuo, Yumi J Hiramine, Yun Wu, PhD, Yvesna C Blaise, Yvins Dezan, Yvonne E Lozano, Zachary A Bogorad, Zachary L Miller, Zerita White, Zhao Wang, PhD, Zhong Li, PhD, Zhongren Wu, Ziyang Su, PhD, Zonglin Hu

Wayne E Seifert's Documents

Publish Date Document Type Title
February, 2017 FDA 483 Catalent Indiana, LLC - Form 483, 2017-02-17
November, 2020 EIR Lonza Biologics, Inc. - EIR, 2020-11-03
April, 2023 FDA 483 Norbitec GmbH - Form 483, 2023-04-06
March, 2021 EIR AGC Biologics, Inc. - EIR, 2021-03-19
May, 2019 FDA 483 Response Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - Form 483R, 2019-05-20
October, 2021 FDA 483 Response Catalent Belgium SA - Form 483R, 2021-11-17
June, 2021 EIR Biogen MA Inc. - EIR, 2021-06-16
February, 2022 FDA 483 UCB Pharma S.A. - Form 483, 2022-02-04
June, 2021 FDA 483 Biogen MA Inc. - Form 483, 2021-06-16
May, 2018 FDA 483 Actavis Italy Spa A Socio Unico - Form 483, 2018-05-04
June, 2019 FDA 483 Woodstock Sterile Solutions - Form 483, 2019-06-25
September, 2018 FDA 483 Novartis Pharma Stein AG - Form 483, 2018-09-21
February, 2022 EIR UCB Pharma S.A. - EIR, 2023-06-07
October, 2021 EIR Catalent Belgium SA - EIR, 2021-10-26
February, 2020 FDA 483 TERUMO YAMAGUCHI CORPORATION - Form 483, 2020-02-21
March, 2022 FDA 483 Shire Human Genetic Therapies, Inc. - Form 483, 2022-03-23
February, 2022 FDA 483 Response Rentschler Biopharma SE - Form 483R, 2022-02-15
May, 2019 FDA 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - Form 483, 2019-05-03
October, 2023 FDA 483 Eli Lilly and Company - Form 483, 2023-10-06
February, 2019 FDA 483 Biofortuna Limited - Form 483, 2019-02-01
November, 2020 EIR Lyophilization Services Of New England, Inc. (LSNE) - EIR, 2020-11-11
September, 2023 FDA 483 Samsung Biologics Co., Ltd. - Form 483, 2023-09-01
February, 2022 EIR Rentschler Biopharma SE - EIR, 2022-02-15
April, 2021 FDA 483 Lyophilization Services Of New England, Inc. (LSNE) - Form 483, 2021-04-19
March, 2023 FDA 483 Fresenius Kabi Austria - Form 483, 2023-03-28
December, 2019 FDA 483 Allergan Pharmaceuticals Ireland - Form 483, 2019-12-17
April, 2017 FDA 483 Wacker Biotech GmbH - Form 483, 2017-04-11
August, 2022 FDA 483 Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - Form 483, 2022-08-26
December, 2021 FDA 483 Sandoz GmbH - Form 483, 2021-12-17
March, 2020 EIR Immunomedics, Inc. - EIR, 2020-03-10
June, 2023 FDA 483 Eli Lilly and Company - Form 483, 2023-06-16
June, 2021 FDA 483 Response Biogen MA Inc. - Form 483R, 2021-07-01
November, 2015 FDA 483 Boehringer Ingelheim Pharma GmbH and Co. KG - Form 483, 2015-11-13
November, 2020 FDA 483 Response Lyophilization Services Of New England, Inc. (LSNE) - Form 483R, 2020-11-20
June, 2022 FDA 483 CELLTRION Inc - Form 483, 2022-06-03
September, 2020 FDA 483 Genzyme Corporation - Form 483, 2020-09-04
March, 2017 FDA 483 Wyeth Pharmaceutical Division of Wyeth Holdings LLC - Form 483, 2017-03-17
July, 2016 FDA 483 FUJIFILM Diosynth Biotechnologies Denmark ApS - Form 483, 2016-07-08
March, 2021 FDA 483 Response AGC Biologics, Inc. - Form 483R, 2021-04-09
September, 2021 FDA 483 BIOCON SDN.BHD. - Form 483, 2021-09-24
September, 2016 FDA 483 Patheon Italia S.p.A - Form 483, 2016-09-07
July, 2023 FDA 483 ImClone Systems LLC - Form 483, 2023-07-27
September, 2019 FDA 483 Samsung Biologics Co., Ltd. - Form 483, 2019-09-10
February, 2018 FDA 483 Patheon Biologics B.V. - Form 483, 2018-02-13
October, 2022 FDA 483 Lupin Limited (Biotech Division) - Form 483, 2022-10-14
November, 2018 EIR Boehringer Ingelheim RCV GmbH & Co KG - EIR, 2018-11-23
November, 2021 FDA 483 Alcon - Couvreur - Form 483, 2021-11-05
May, 2023 FDA 483 Catalent Indiana, LLC - Form 483, 2023-05-12
April, 2021 EIR Lyophilization Services Of New England, Inc. (LSNE) - EIR, 2021-04-19
November, 2015 EIR Boehringer Ingelheim Pharma GmbH and Co. KG - EIR, 2015-11-24
October, 2021 FDA 483 Catalent Belgium SA - Form 483, 2021-10-26
November, 2020 FDA 483 Lyophilization Services Of New England, Inc. (LSNE) - Form 483, 2020-11-11
January, 2023 FDA 483 PACKAGING COORDINATORS LLC - Form 483, 2023-01-12
September, 2020 EIR Genzyme Corporation - EIR, 2020-09-04
January, 2016 FDA 483 F. Hoffmann-La Roche AG - Form 483, 2016-01-22
December, 2019 FDA 483 Response Allergan Pharmaceuticals Ireland - Form 483R, 2019-12-17
November, 2023 FDA 483 FUJIFILM Diosynth Biotechnologies Texas, LLC - Form 483, 2023-11-07
June, 2015 FDA 483 Eli Lilly Kinsale Limited - Form 483, 2015-06-26
November, 2020 FDA 483 Lonza Biologics, Inc. - Form 483, 2020-11-03
May, 2019 EIR Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - EIR, 2019-05-03
November, 2018 FDA 483 Boehringer Ingelheim RCV GmbH & Co KG - Form 483, 2018-11-23
August, 2022 FDA 483 Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) - Form 483, 2022-08-19
July, 2017 FDA 483 Glaxo Operations UK Ltd - Form 483, 2017-07-04
March, 2021 FDA 483 AGC Biologics, Inc. - Form 483, 2021-03-19
February, 2022 FDA 483 Response UCB Pharma S.A. - Form 483R, 2022-02-25
February, 2022 FDA 483 Rentschler Biopharma SE - Form 483, 2022-02-15
March, 2020 FDA 483 Immunomedics, Inc. - Form 483, 2020-03-10
December, 2022 FDA 483 Novartis Pharma Stein AG - Form 483, 2022-12-06
June, 2024 FDA 483 AstraZeneca Pharmaceuticals LP - Form 483, 2024-06-07
May, 2024 FDA 483 Pfizer Manufacturing Belgium NV - Form 483, 2024-05-17
September, 2024 FDA 483 Baxter Pharmaceutical Solutions LLC - Form 483, 2024-09-24

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