FDA Investigator James R Birkenstamm

James R Birkenstamm has inspections in 4 countries as of 29 Aug 2023. James R Birkenstamm has collaborated with a combinined 2746 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
49
Last Inspection Date:
29 Aug 2023
Investigator Role:
FDA Investigator
Redica ID:
100002836
Country:
Germany, United States of America, Korea (Republic of), Thailand
Co-Investigator(s):
Addam S Reynolds, Adetutu M Gidado, Alberto A Viciedo, Alice S Tsao, Amy L Singer, Amy M Codella, Amy M Cramer, Ankur C Patel, Anna M Brannen, Annemarie B Randow, Annemarie Bodnar, Arthur T Ogdahl, Ashley J Burns, Atul J Agrawal, Barbara Jwilimczyk Macri, Bonita S Chester, Byungja E Marciante, Cassandra L Abellard, Charles I Ann, Christopher S Keating, Daniel J Grabicki, Daniel J Min, David A Oluwo, David H Smith, 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 Oshaughnessy, Elaine E Gilfillan, Emest Bizjak, Emest F Bizjak, Emmanuel J Ramos, Erika E Englund, PhD, Ernest F Bizjack, Esteban Beltran, Felix Maldonado, Frank J Marciniak, Frederick Razzaghi, George J Flynn, Gianine E Tompkins, Gobiga Vanniyasingam, Guerlain Ulysse, Helen Verdel, Janet A Rajan, Jay B Shah, Jean Blackston Hill, Jean Blackstone Hill, Jennifer J Stone, Jennifer L Custodio, Jennifer L Huntington, Jennifer Macmillan, Jessica M Monteiro, Joanne E King, Jogy George, John A Gonzalez, John D White, Johnna L Bleem, Jonathan S Helfgott, Jonee J Mearns, Jose Acruz Gonzalez, Jose M Cayuela, Jot R Klena, 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, Lenahan Lenahan, Peter R, Liatte Kreuger, PharmD, Lisa M Bellows, Lisa M Feola, Loretta Nemchik, Lucila B Nwatu, Luella J Rossi, Marea K Harmon, Margaret M Annes, Margaret M Sands, Maria A Bienkowski, Maria A Reed, Maria Estrella, Marie Bbuen 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, Mihaela Jason, Monika Borkowska, Nancy F Scheraga, Nancy L Rolli, Nancy M Espinal, Nerizza B Guerin, Nicholas A Violand, Niketa Patel, Nina Yang, Nyungja E Marciente, Odera I Ekwunife, Patrick C Klotzbuecher, Paul L Bellamy, Paul Mouris, Peter R Lenahan, Pushpa S Jayasekara, Qin Xu, Ramon A Hernandez, Raymond L Cheung, Rebecca Rodriguez, Regina T Brown, Richard J Muzeni, Roger F Zabinski, Rose Ljean Mary, 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, Steven M Weinman, Syeda N Mahazabin, Tamil Arasu, PhD, Tanya R Syffrard, Temar Q Williams, Thomas E Friel, Tiffani D Wilson, Tonia F Bernard, Unnee Ranjan, Victoria Spivak, William J Muszynski, William R Chang, Yvins Dezan

James R Birkenstamm's Documents

Publish Date Document Type Title
July, 2021 FDA 483 Response SPECTRUM LABORATORY PRODUCTS INC. dba SPECTRUM CHEMICAL MFG. CORP. - Form 483R, 2021-07-14
January, 2018 FDA 483 Flawless Beauty LLC - Form 483, 2018-01-10
January, 2018 FDA 483 Response Flawless Beauty LLC - Form 483R, 2018-01-10
March, 2018 FDA 483 Response Alcami Corporation - Form 483R, 2018-04-09
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
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
July, 2017 EIR Amneal Pharmaceuticals, LLC - EIR, 2017-07-27
February, 2019 FDA 483 Amneal Pharmaceuticals, LLC - Form 483, 2019-02-21
July, 2017 FDA 483 Amneal Pharmaceuticals, LLC - Form 483, 2017-07-27
November, 2018 FDA 483 APPCO PHARMA LLC - Form 483, 2018-11-06
May, 2018 FDA 483 Primera Analytical Solutions Corporation - Form 483, 2018-05-18
March, 2023 FDA 483 Cetylite Industries, Inc. - Form 483, 2023-03-02
April, 2019 FDA 483 Aurohealth LLC - Form 483, 2019-04-11
April, 2019 FDA 483 Response Aurohealth LLC - Form 483R, 2019-05-02
March, 2023 FDA 483 Response Cetylite Industries, Inc. - Form 483R, 2023-03-02
February, 2020 FDA 483 Ohm Laboratories Inc. - Form 483, 2020-02-05
February, 2020 EIR Ohm Laboratories Inc. - EIR, 2020-02-05
April, 2017 FDA 483 Scientech Laboratories, Inc. - Form 483, 2017-04-25
May, 2017 EIR InvaDerm Corporation - EIR, 2017-05-30
May, 2018 FDA 483 Response Primera Analytical Solutions Corporation - Form 483R, 2018-06-07
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
June, 2023 FDA 483 InvaDerm Corporation - Form 483, 2023-06-28
December, 2023 FDA 483 Eugia US Manufacturing LLC - Form 483, 2023-12-22

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