FDA Investigator James R Birkenstamm

James R Birkenstamm has conducted inspections on 53 sites in 4 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:
53
Last Inspection Date:
20 May 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, Thailand, Korea (Republic of), Germany
FDA Investigators that have inspected at least one site in common with James R Birkenstamm:
Addam S Reynolds, Adetutu M Gidado, Alberto A Viciedo, Alice S Tsao, Alisha B Patel, Amy L Singer, Amy M Codella, Amy M Cramer, Ana P Barido, Ankur C Patel, Anna M Brannen, Annemarie B Randow, Annemarie Bodnar, Anthony J Donato, Arthur T Ogdahl, Ashley J Burns, Atul J Agrawal, Barbara Jwilimczyk Macri, Bei Yu, Bonita S Chester, Brandon L Mariner, Byungja E Marciante, Cassandra L Abellard, Charles I Ann, Charles R Bonapace, PhD, Christina K Theodorou, Christopher S Keating, Craig D Zagata, Daniel J Grabicki, Daniel J Min, Daniel L Zheng, David A Oluwo, David H Smith, David L Chon, Dawn L Wydner, Denise M Digiulio, Denise M Visco, Investigator, Devon Jenkins, Dhaval H Patel, Doreen P Gubbay, Douglas C Kovacs, Dr. Robert C Horan, MD, Edward O'shaughnessy, Ekaterina Allen, Elaine E Gilfillan, Elena N Thomas, Emest F Bizjak, Emily A Walters, Emmanuel Jramos Maldonado, Erika E Englund, PhD, Esteban Beltran, Felix Maldonado, Frank J Marciniak, Frederick F Razzaghi, George J Flynn, Gianine E Tompkins, Gobiga Vanniyasingam, Guerlain Ulysse, Hector Jcolon Torres, Helen Verdel, Ifechimere I Okafor, Jacqueline S Warner, Janet A Rajan, Jay B Shah, Jazmine N Brown, Jean Blackston Hill, Jean M Mulinde, MD, Jennifer J Stone, Jennifer L Custodio, Jennifer L Huntington, Jennifer Macmillan, Jenny Sung, Jessica M Monteiro, Jessica S Estriplet, Joanne E King, Jogy George, John A Gonzalez, John D White, John Dan, Johnna L Bleem, Jonathan S Helfgott, Jonee J Mearns, Jose Acruz Gonzalez, Jose M Cayuela, Joy Rkozlowski Klena, Justine Tomasso, Karen F Tomaziefski, Karishma G Gopaul, Katherine Szestypalow, Kelli F Dobilas, Kham Phommachanh, Ko U Min, Kristen E Rescigno, Kristina L Conroy, Kristy A Zielny, Larry K Austin, Lata C Mathew, PhD, Lauren L Vajo, Lawrence Harmon, Jr, Lee Hong Pai Scherf, Liatte Kreuger, PharmD, Lisa M Bellows, Lisa M Feola, Loretta Nemchik, Lori S Lawless, Lucila B Nwatu, Luella J Rossi, Marea K Harmon, Margaret M Annes, Margaret M Sands, Maria A Bienkowski, Maria A Reed, Maria Estrella, Marie B Buen Bigornia, Mary E Storch, Megan A Haggerty, Melissa T Roy, Meredith L Sheridan, Meyer J Slobotsky, Michael A Charles, Michael A Taylor, Michael L Chasey, Michael R Klapal, Michael Serrano, Miguel A Martinez Perez, Mihaela Jason, Monika Borkowska, Nancy F Scheraga, Nancy L Rolli, Nancy M Espinal, Nebil A Oumer, Nerizza B Guerin, Nicholas A Violand, Niketa Patel, Nina Yang, Odera I Ekwunife, Patrick C Klotzbuecher, Paul L Bellamy, Paul Mouris, Peter R Lenahan, Puspa Suresh Jayasekara, Qin Xu, Ramon A Hernandez, Raymond L Cheung, Rebecca Rodriguez, Regina T Brown, Richard J Muzeni, Robin R Waller, Roger F Zabinski, Rose Ljean Mary, Ruben C Quintana, Russell J Glapion, Samir C Gala, Sandra A Hughes, Sarah Forney, Satheesh K Podaralla, Sayyem H Akbar, Sean G Casey, Sripal R Mada, PhD, Stephanie T Durso, Stephen J Koniers, Stephen J Mottola, Stephenie M Ortiz, Steven M Weinman, Suchan Kim, Syeda N Mahazabin, Tamil Arasu, PhD, Tammy L Chavis, Tanya R Syffrard, Temar Q Williams, Thomas E Friel, Tiffani D Wilson, Tonia F Bernard, Tyanna N Hadley, Unnee Ranjan, Victoria Spivak, William J Muszynski, William R Chang, Yaharn Su, Yangmin Ning, Yoriann M Cabrera Bartolomei, Yvins Dezan

James R Birkenstamm's Documents

Publish Date Document Type Title
August, 2022 FDA 483 A.P. Deauville, LLC - Form 483, 2022-08-25
March, 2023 FDA 483 Cetylite Industries, Inc. - Form 483, 2023-03-02
February, 2019 FDA 483 Amneal Pharmaceuticals, LLC - Form 483, 2019-02-21
April, 2017 FDA 483 Scientech Laboratories, Inc. - Form 483, 2017-04-25
February, 2020 FDA 483 OHM LABORATORIES INC. - Form 483, 2020-02-05
March, 2023 FDA 483 Response Cetylite Industries, Inc. - Form 483R, 2023-03-02
July, 2021 FDA 483 Response SPECTRUM LABORATORY PRODUCTS INC. dba SPECTRUM CHEMICAL MFG. CORP. - Form 483R, 2021-07-14
April, 2019 FDA 483 Response Aurohealth LLC - Form 483R, 2019-05-02
July, 2017 FDA 483 Amneal Pharmaceuticals, LLC - Form 483, 2017-07-27
March, 2018 FDA 483 Response Alcami Corporation - Form 483R, 2018-04-09
July, 2017 EIR Amneal Pharmaceuticals, LLC - EIR, 2017-07-27
October, 2016 FDA 483 Response RARITAN PHARMACEUTICALS INCORPORATED - Form 483R, 2016-11-03
July, 2021 EIR SPECTRUM LABORATORY PRODUCTS INC. dba SPECTRUM CHEMICAL MFG. CORP. - EIR, 2021-07-14
May, 2018 FDA 483 Primera Analytical Solutions Corporation - Form 483, 2018-05-18
January, 2018 FDA 483 Response Flawless Beauty LLC - Form 483R, 2018-01-10
November, 2018 FDA 483 APPCO PHARMA LLC - Form 483, 2018-11-06
April, 2019 FDA 483 Aurohealth LLC - Form 483, 2019-04-11
July, 2021 FDA 483 SPECTRUM LABORATORY PRODUCTS INC. dba SPECTRUM CHEMICAL MFG. CORP. - Form 483, 2021-07-19
June, 2017 EIR InvaDerm Corporation - EIR, 2017-06-15
January, 2018 FDA 483 Flawless Beauty LLC - Form 483, 2018-01-10
May, 2017 EIR InvaDerm Corporation - EIR, 2017-05-30
October, 2016 FDA 483 RARITAN PHARMACEUTICALS INCORPORATED - Form 483, 2016-10-20
March, 2018 EIR Alcami Corporation - EIR, 2018-03-19
October, 2023 FDA 483 DuPont Nutrition USA, Inc - Form 483, 2023-10-25
December, 2023 FDA 483 Eugia US Manufacturing LLC - Form 483, 2023-12-22
May, 2018 FDA 483 Response Primera Analytical Solutions Corporation - Form 483R, 2018-06-07
June, 2023 FDA 483 InvaDerm Corporation - Form 483, 2023-06-28
February, 2020 EIR OHM LABORATORIES INC. - EIR, 2020-02-05
June, 2019 FDA 483 Premier Trends LLC - Form 483, 2019-06-28
May, 2024 FDA 483 AstraZeneca Pharmaceuticals LP - Form 483, 2024-05-31

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