FDA Investigator Erik W Koester

Erik W Koester has inspections in 8 countries as of 01 Nov 2023. Erik W Koester has collaborated with a combinined 5819 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
119
Last Inspection Date:
01 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
100001030
Country:
United States of America, Italy, Australia, India, Canada, Portugal, Switzerland
Co-Investigator(s):
Abby E Pelletier, Abdur Rafay Shareef, Ademola O Daramola, Alberto A Viciedo, Alice C Silva, Alice Canty, Alice S Tsao, Alison N Stieg, Allison A Aldridge, PhD, Allison A Rodriguez, Alois P Provost, Alysia M Salonia, Amber G Wardwell, Amy C Jordan, Andrea A Branche, Andrew M Abramowitz, Andrew M Barlow, Angela E Glenn, Angela J Davis, Annet R Rajan, Anthony C Warchut, Arie C Menachem, Armen H Youssoufian, Arsen Karapetyan, Barbara A Gullick, Bijoy Panicher, Bijoy Panicker, Bo Chi, PhD, Bradford L Swanson, Bradley D Newsad, Brenda P King, Brenna L Macdowell, Brooke K Higgins, Burnell M Henry, Byungja E Marciante, Camerson E Moore, Carl A Perez, Cassandra L Abellard, Chaltu N Wakijra, Charisse K Green, Charles R Cote, RIC, Charles Yuanchia Kuo, PhD, Charlotte Hinkle, Chhaya S Shetty, Chiang Syin, PhD, Christian D Lynch (CDL), Christina K Theodorou, Christopher Janik, Christopher K Vantwuyver, Clifton L Randell, Constance Desimone, Crystal Monroy, Cynthia Jim, CSO, Cynthia Whitmarsh, Dana A Razzano, Daniel L Zheng, Darin S Wiegers, Darren S Brown, Daryl A Dewoskin, David A Oluwo, David P Vanhouten, David Van Houten, Dawn E Barkans, Dawn M Braswell, Demitria J Xiradakis, Deyaa Shaheen, Diane C Thibodeau, Dien N Nguyen, Donald C Obenhuber, PhD, Donald G Gordon, Dongping Dai, PhD, Douglas A Campbell, Douglas S Joslin, Dr. Dominick Roselle, Dr. Robert C Horan, MD, Dr. Roslyn F Powers, Dr. Yubing Tang, Edmund F Mrak, Jr, Elizabeth B Griffin, Elizabeth Ll Edwards, Ellen P Madigan, Emest F Bizjak, Eric L Dong, BS, Eric M Silberhorn, Erik M Koester, Erk W Koester, Felix Maldonado, Frank Wackes, Frederick Razzaghi, Gam S Zamil, Garry H Stewart, Gary J Hagan, Gary J Lehr, Gary T Greco, George Pyramides, Gerard D Difiore, Graeme E Price, Haley H Seymour, Harlan J Howard, Harperd, Hector J Colon Torres, Helen B Ricalde, Helen Verdel, Holly Brevig, Holly M Zahner, Hugh M Mcclure, II, James A Liubicich, James L Dunnie, Jr, James M Mason, James M Simpson, James W Whitney, Jason A Rossi, Jay T Wong, Jayaleka J Amarasinghe, Jeffrey J Thibodeau, Jennifer T Szymanski, Jie He, John J Thibodeau, John P Mistler, John P Shelton, John R Carlson, John S Hartford, Jonah S Ufferfilge, Jonah Ufferfilge, Jonathan G Matrisciano, Jonathan W Chapman, Jose Acruz Gonzalez, Jose E Melendez, DDC, Jose M Cayuela, Jose O Hernandez, Joseph H Procopio, Joseph W Matthews, Josh Renzon Ramilo, Joshua S Hunt, Joyce A Kellett, Junho Pak, Justin A Boyd, Justine M Corson, Karen A Briggs, Katherine D Adams, Katherine L Huebner, Katherine Szestypalow, Kathleen E Mcafoose, Kathleen M Jordan, Katie L Korchinski, Kenneth Gordon, Kenneth H Williams, Kenneth M Gordon, Kenneth Nieves, Kent A Conforti, Kevin A Gonzalez, Kevin D Kallander, Kham Phommachanh, Kim Lthomas Cruse, Kimberly M White, Ko U Min, Kristina J Donohue, Kristina L Conroy, Lane V Christensen, PhD, Lashanda M Long, Lauren N Barber, Laurie B Frazier, Lawrence Harmon, Jr, Lawrence W Farina, LCDR Chad N Thompson, LCDR Debra Emerson, LCDR Michael H Tollon, Leanna M Slarsky, Leo B Zadecky, Li Yun Huang, Linda L Green, Linda Thai, Lori A Holmquist, Lori M Newman, Lori S Lawless, Louis Christy, Lucas B Leake, Maotang Zhou, PhD, Marc S Neubauer, Marcellinus D Dordunoo, Marcus A Ray, Margaret E Sarles, Margaret E Walsh, Margaret M Doherty, Margaret M Sands, Marie Bbuen Bigornia, Mariza M Jafary, Mark E Parmon, Mark R Mcclain, Marlene L Davis, Martin J Guardia, Mary Jeanet Mcgarry, Maryam Tabatabaie, Marybet Lopez Negron, Matthew C Watson, Matthew D Silverman, Matthew M Henciak, Maty Mcgarry, Maura Rooney, Maxim, Maya M Davis, Megan A Haggerty, Meisha A Mandal, Melissa J Garcia, Michael E Maselli, Michael J Casey, Michael L Casner, Michael P Anthony, Michael P Sweeney, Michael Shanks, MS, Michelle A Marsh, Michelle M Noe, Mihaly S Ligmond, Mikayla K Deardorff, Mindy M Chou, Monica Commerford, PhD, Nabil Nakhoul, Nadeem I Chaudhry, Nancy M Espinal, Nariman Patenaude, Nazmul Hassan, Nealie C Newberger, Nebil A Oumer, Nicholas A Violand, Niketa Patel, Nirjal Bhattarai, Obinna R Echeozo, Omotunde O Osunsanmi, Paraluman S Leonin, Parul M Patel, Patricia Fhughes Troost, Patrick C Klotzbuecher, Paul E Stein, Paul L Bellamy, Paula M Laplant, Peter Abel, Philip Kreiter, Phillip E Mclaughlin, Prabhu P Raju, Rachael A Moliver, Rachael O Oyewole, Rachael Oyewole, Rachel C Harrington, Raeann R Wu, Rajiv R Srivastava, Ramon E Martinez, Rebecca A Coleman, Rebecca B Welch, Rebecca E Cluster, Rebecca E Dombrowski, Rebecca Rodriguez, Regina T Brown, Richard A Abate, Richard B Mcaroy, Richard H Penta, Robert C Steyert, Robert H Wittorf, Robert J Ham, Robert J Martin, Robert J Veitch, Robert Mo Brien, Robert W Jennings, Rory K Geyer, Roy R Rinc, Saleem A Akhtar, Samantha J Bradley, Samina S Khan, Samir C Gala, Samuel J Arsenault, Samuel K Mathew, Samuel Mathew, Sandra P White, Sangeeta M Khurana, PhD, Sara M Onyango, Sara M Richardson, Scott C Lute, Scott Lute, Sean R Marcsisin, Shari L Kahn, Sharon K Thoma, PharmD, Sherry K Markwell, Shirley S Wen, Shirshendu K Deb, PhD, Simone E Pitts, Slater K Bartlett, Sony Mathews, Stacey S Degarmo, Stanley Au, State Agency, Stephen C Smith, Stephen D Brown, Steve Y Rhieu, PhD, Susan M Jackson, Susanne M Richardson, MSc RAC ELS, Suzanne M Healy, Tamara M Kays, Terry Bridgewater, Thomas E Friel, Thomas H Jenkins, Thomas J Arista, Thomas J Mooney, Thuy T Nguyen, LCDR, Tonia F Bernard, Towanda L Terrell, Toyin B Oladimeji, Troy R Petrillo, Ucheabuchi C Chudi Nwankwor, Valentino Fiorella, Victor J Gangi, Victoria M Daddeo, Viviana Matta, Viviana R Ramirez, Vivin George, Walter L Fava, Wanda Y Honeyblue, Wayne E Seifert, William M Rennells, Xiaokuang Lai, PhD, Xiaoping Guan, Xikui Chen (nmi), PhD, Yaodong Huang, Yong Wang, Yumi J Hiramine, Yvins Dezan, Ze Peng, Zhihao Qiu (Peter), PhD, Zhongren Wu

Erik W Koester's Documents

Publish Date Document Type Title
March, 2018 FDA 483 Tower Laboratories Ltd - Form 483, 2018-03-23
January, 2020 EIR Azurity Pharmaceuticals, Inc. - EIR, 2020-01-15
April, 2018 EIR Berkshire Sterile Manufacturing, Inc. - EIR, 2018-04-13
November, 2022 FDA 483 Pharmaceutics International, Inc. - Form 483, 2022-11-14
February, 2022 FDA 483 Azurity Pharmaceuticals, Inc. - Form 483, 2022-02-24
July, 2016 FDA 483 Response PHARMARON MANUFACTURING SERVICES (US) LLC - Form 483R, 2016-08-15
August, 2017 FDA 483 Response New England Life Care, d/b/a Advanced Compounding Solutions - Form 483R, 2017-09-08
May, 2022 FDA 483 Berkshire Sterile Manufacturing, Inc. - Form 483, 2022-05-23
December, 2016 FDA 483 Response Charles River Laboratories, Inc. - Form 483R, 2016-12-22
November, 2022 EIR Pharmaceutics International, Inc. - EIR, 2022-11-14
November, 2019 EIR Associates of Cape Cod, Inc. - EIR, 2019-11-26
November, 2017 FDA 483 Sun Pharmaceutical Industries, Inc. - Form 483, 2017-11-13
February, 2023 FDA 483 Nitto Denko Avecia Inc. - Form 483, 2023-03-29
July, 2016 EIR PHARMARON MANUFACTURING SERVICES (US) LLC - EIR, 2016-07-27
May, 2017 FDA 483 ARIAD Pharmaceuticals - Form 483, 2017-05-31
October, 2019 FDA 483 Bluepharma - IndÚstria FarmacÊutica, S.a. - Form 483, 2019-10-18
May, 2018 FDA 483 Nitto Denko Avecia Inc. - Form 483, 2018-05-10
February, 2017 EIR Lyophilization Services Of New England, Inc. (LSNE) - EIR, 2017-02-15
December, 2016 EIR Charles River Laboratories, Inc. - EIR, 2016-12-06
August, 2018 EIR Trividia Manufacturing Solutions - EIR, 2018-08-24
September, 2015 FDA 483 Specialty Minerals Incorporated - Form 483, 2015-09-18
March, 2019 FDA 483 AllerQuest LLC - Form 483, 2019-03-01
June, 2019 FDA 483 American International Chemical, LLC - Form 483, 2019-06-26
October, 2016 FDA 483 Tropical Products Inc - Form 483, 2016-10-14
April, 2018 FDA 483 Berkshire Sterile Manufacturing, Inc. - Form 483, 2018-04-13
September, 2016 FDA 483 Veranova, L.P. - Form 483, 2016-09-02
December, 2022 FDA 483 Chartwell Pharmaceuticals Amityville, LLC. - Form 483, 2022-12-21
April, 2018 FDA 483 Response Berkshire Sterile Manufacturing, Inc. - Form 483R, 2018-05-04
November, 2021 FDA 483 Edge Pharma, LLC - Form 483, 2021-11-30
August, 2019 FDA 483 EyePoint Pharmaceuticals US, Inc. - Form 483, 2019-08-28
October, 2015 FDA 483 Safecor Health, LLC - Form 483, 2015-10-27
December, 2019 FDA 483 Sun Pharmaceutical Industries, Inc. - Form 483, 2020-01-06
March, 2016 FDA 483 PETNET SOLUTIONS, INC. - Form 483, 2016-03-03
October, 2018 FDA 483 Johnson Memorial Cancer Center - Form 483, 2018-10-19
June, 2016 FDA 483 Pharmalucence Inc. - Form 483, 2016-06-29
September, 2021 FDA 483 BRIGHAM AND WOMEN`S HOSPITAL, INC., THE - Form 483, 2021-09-16
September, 2023 FDA 483 Lyophilization Services Of New England, Inc. (LSNE) - Form 483, 2023-09-27
November, 2022 FDA 483 Pharmaceutics International, Inc. - Form 483, 2022-11-14
November, 2019 FDA 483 Associates of Cape Cod, Inc. - Form 483, 2019-11-26
May, 2018 EIR Nitto Denko Avecia Inc. - EIR, 2018-05-10
November, 2014 FDA 483 Citra Labs, LLC - Form 483, 2014-11-21
February, 2018 FDA 483 Braintree Laboratories, Inc. - Form 483, 2018-02-28
April, 2019 FDA 483 PLZ Corp - Form 483, 2019-04-03
February, 2018 FDA 483 The Original Bradford Soap Works Inc - Form 483, 2018-02-02
September, 2017 FDA 483 Anika Therapeutics Inc - Form 483, 2017-09-21
April, 2023 FDA 483 Tender Corporation - Form 483, 2023-04-26
July, 2022 FDA 483 Ensign Laboratories Proprietary Limited - Form 483, 2022-07-15
February, 2020 FDA 483 Charles River Laboratories, Inc. - Form 483, 2020-02-11
December, 2017 FDA 483 Church & Dwight Canada Corp. - Form 483, 2017-12-08
August, 2023 FDA 483 Anika Therapeutics Inc - Form 483, 2023-08-09
June, 2018 FDA 483 Catalent Massachusetts, LLC - Form 483, 2018-06-18
July, 2016 FDA 483 Rhodes Technologies - Form 483, 2016-07-27
April, 2022 FDA 483 Brookfield Medical/Surgical Supply, Inc. - Form 483, 2022-04-04
March, 2017 FDA 483 Putney Inc. - Form 483, 2017-03-09
December, 2017 FDA 483 Cosmaceutical Research Laboratory Inc - Form 483, 2017-12-15
December, 2017 FDA 483 Les Importations Herbasante Inc - Form 483, 2017-12-01
January, 2020 EIR Strem Chemicals, Inc - EIR, 2020-02-04
September, 2022 FDA 483 South Berwick Pharmacy Seacoast Compounding, Inc. - Form 483, 2022-09-30
October, 2017 FDA 483 Safecor Health, LLC - Form 483, 2017-10-19
March, 2020 FDA 483 Response Edge Pharma, LLC - Form 483R, 2020-05-01
May, 2016 FDA 483 Tender Corporation - Form 483, 2016-05-31
January, 2016 FDA 483 Arzol Chemical Company - Form 483, 2016-01-25
August, 2017 FDA 483 New England Life Care, d/b/a Advanced Compounding Solutions - Form 483, 2017-08-22
March, 2020 FDA 483 Edge Pharma, LLC - Form 483, 2020-03-30
May, 2018 FDA 483 Response Nitto Denko Avecia Inc. - Form 483R, 2018-05-30
January, 2020 FDA 483 Response Azurity Pharmaceuticals, Inc. - Form 483R, 2020-02-04
June, 2016 FDA 483 EMD Serono, Inc. - Form 483, 2016-06-17
December, 2018 FDA 483 Fresenius Kabi Compounding, LLC - Form 483, 2018-12-04
July, 2021 FDA 483 Lohxa - Form 483, 2021-07-19
September, 2016 FDA 483 Response Veranova, L.P. - Form 483R, 2016-09-22
November, 2019 FDA 483 Response Associates of Cape Cod, Inc. - Form 483R, 2019-12-13
July, 2016 EIR Rhodes Pharmaceuticals L.P. - EIR, 2016-07-27
January, 2017 FDA 483 Shire Human Genetic Therapies, Inc. - Form 483, 2017-01-20
September, 2016 EIR Veranova, L.P. - EIR, 2016-09-02
November, 2022 EIR Pharmaceutics International, Inc. - EIR, 2022-11-14
July, 2022 FDA 483 Baxter Laboratories Pty. Ltd. - Form 483, 2022-07-22
June, 2019 EIR American International Chemical, LLC - EIR, 2019-06-26
May, 2022 FDA 483 Response Berkshire Sterile Manufacturing, Inc. - Form 483R, 2022-05-23
November, 2020 FDA 483 Hopkinton Drug, Inc. - Form 483, 2020-11-10
January, 2017 EIR Shire Human Genetic Therapies, Inc. - EIR, 2017-01-05
January, 2020 FDA 483 Azurity Pharmaceuticals, Inc. - Form 483, 2020-01-15
December, 2018 FDA 483 Brookfield Medical/Surgical Supply, Inc. - Form 483, 2018-12-21
December, 2016 FDA 483 Charles River Laboratories, Inc. - Form 483, 2016-12-06
April, 2017 FDA 483 Biogen, Inc. - Form 483, 2017-04-06
March, 2023 FDA 483 Shawsheen Rubber Co., Inc. dba Arrowhead Athletics - Form 483, 2023-03-13
February, 2016 FDA 483 Sheffield Pharmaceuticals LLC - Form 483, 2016-02-18
April, 2017 FDA 483 Bristol-Myers Squibb Company - Form 483, 2017-04-05
September, 2019 FDA 483 Primeline - Form 483, 2019-11-05
February, 2022 EIR Azurity Pharmaceuticals, Inc. - EIR, 2022-03-15
November, 2023 FDA 483 Curia New York, Inc. - Form 483, 2023-11-01
December, 2023 FDA 483 TITAN KOGYO ,LTD. - Form 483, 2023-12-08
September, 2019 FDA 483 Primeline - Form 483, 2019-11-05
January, 2024 FDA 483 scPharmaceuticals Inc. - Form 483, 2024-01-25
December, 2023 FDA 483 TAYCA CORPORATION - Form 483, 2023-12-01

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