FDA Investigator José E Meléndez

José E Meléndez has conducted inspections on 209 sites in 33 countries as of 15 Apr 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
209
Last Inspection Date:
15 Apr 2024
Investigator Role:
FDA Investigation Participant
Redica ID:
Countries of Inspections:
India, China, France, United States of America, Italy, Romania, Puerto Rico, Malaysia, Japan, Dominican Republic, Thailand, South Africa, Mexico, Argentina, Ireland, Finland, Denmark, Belgium, Malta, Australia, Switzerland, Canada, Spain, Singapore, Portugal, New Zealand, Korea (Republic of), Hong Kong, Trinidad and Tobago, United Kingdom of Great Britain and Northern Ireland, Brazil, Germany, Czechia
FDA Investigators that have inspected at least one site in common with José E Meléndez:
Abby Lmozeke Baker, Abigail A Auster, Adalberto Cajigas, Adaliz Santaliz Cruz, Adam R Cooke, Ademola O Daramola, Adetutu M Gidado, Agnes M Santori, Alan A Rivera, Alan P Kurtzberg, Alberto A Viciedo, Alice S Tsao, Alicia M Mozzachio, Amy C Jordan, Amy N Chen, Ana M Rivera, Ana P Pineda Zavaleta, Anastasia M Shields, Andrea A Branche, Andrea George, PhD, Andrew B Bevill, Angela E Glenn, Angelica M Hernandez, Anissa M Vargas, Anita Narula, PhD, Anita R Michael, Anitha Palamakula Govada, Anjali Shukla, PhD, Ann L Demarco, Anna Lazar, Anna M Brannen, Annette Melendez, Anthony A Charity, Ariel Cruz Figueroa, Arlene M Badillo, Arsen Karapetyan, Arwa S El Hagrasy, Ashar P Parikh, Ashley N Queen, PhD, Atul J Agrawal, Azza Talaat, Barbara I Rogolsky, Barbara J Rincon, Barbara Janine Breithaupt, Barbara M Frazier, Bernice F Hirsch, Bijoy Panicker, Bill Tacket, Jr, Bingchen Du, PhD, Binh T Nguyen, Bo Chi, PhD, Brenda Rivera, Brenda S Zimmer, PhD, Brett R Havranek, Burnell M Henry, Calvin B Koerner, Carl A Huffman, III, Carl Lee, Carla A Norris, Carla J Lundi, Carlos A Medina, Cassandra L Abellard, CDR Donald Ertel, CDR Ileana Barreto Pettit, CDR Sean T Creighton, Charanjeet Jassal, Charisse K Green, Charles I Ann, Charles M Edwards, Charles R Cote, RIC, Cheryl A Clausen, Christina Capacci Daniel, PhD, Christine W Twohy, Christopher D Leach, Christopher D Rush, Christopher Downey, PhD, Christopher M Jenner, Christopher S Keating, Christopher T Peters, Colleen F Hoyt, Colleen Thomas, PhD, Concepcion Cruz, Jr, Constance Y Fears, Constantin Y Philopoulos, Cynthia Jim, CSO, Damaris Y Hernandez, Daniel J Lahar, Daniel J Roberts, Daniel L Obrzut, Darla J Christopher, Darren S Brown, Daryl A Dewoskin, David A Oluwo, David J Eide, David J Gomes, David M Beltran, Dawn M Mccabe, Dayna I Martinez, Debra J Bennett, Dell S Moller, Denise M Digiulio, Dennis Cantellops Paite, Deyaa Shaheen, Diane L Raccasi, Dien N Nguyen, Dipesh K Shah, Djamila Harouaka, Doan T Nguyen, PharmD, Donald C Obenhuber, PhD, Donald L Lech, Dongping Dai, PhD, Donna Christner, Douglas A Campbell, Douglas C Kovacs, Dov H Pluznik, PhD, Dr. Barbara D Paul, PhD, Dr. Carmelo Rosa, Dr. Jason R Caballero, Dr. Robert C Horan, MD, Dr. Zhihao Qiu (Peter), PhD, Edmund F Mrak, Jr, Edwin Martinez, Edwin Melendez, Edwin Ortega, Eileen A Liu, Eliezar Ramos, Elizabeth D Connell, Emest F Bizjak, Enrique Galan, Ephrem Hunde, PhD, Eric L Dong, BS, Eric M Mueller, PharmD, Erika E Englund, PhD, Erika V Butler, Eva I Merced Medina, Farhana Khan, Felix Maldonado, Frances L Dejesus, Francis A Guidry, Freddy Ortiz Colon, Frederick L Fricke, Gam S Zamil, George Pyramides, Gerald B Seaborn, Jr, Gerardo Z Vazquez, German Rivera, Gretchen Lf Trendel, Gwyn G Dickinson, Haitao Li, Hamet M Toure, PharmD MPH, Harry J Brewer, Hector Espinet, Hector Jcolon Torres, Helen B Ricalde, Helen Verdel, Holly Brevig, Iraida Ortiz, Ivis L Negron, J Elkins, Jacek Cieslak, PhD, Jacqueline Mdiaz Albertini, Jaime E Pares, James C Maclaughlin, James L Dunnie, Jr, James S Cartwright, Jason F Chancey, Javier E Santos, Javier O Vega, Jay T Wong, Jay V Jariwala, Jeffery A Hangartner, Jeffrey A Sommers, Jennifer D Hollstrom, Jennifer L Huntington, Jennifer Lalama, Jeremy W Rotton, Jerri Baker, Joan M Cantellops Figueroa, Joanne E King, Joe X Phillips, Joel D Hustedt, Joey V Quitania, Jogy George, Johann M Fitch, John A Gonzalez, Jonathan W Chapman, Jorge E Martinez, Jorge L Gonzalez, Jorge L Guadalupe, Jorge L Lajara, Jose A Lopez, Jose A Moreno, Jose Acruz Gonzalez, Jose F Pedro, Jose M Cayuela, Jose Martinez, Jr, Jose Perez Soto, Jose R Hernandez, Jose R Lopez, Jose Rflores Veguilla, Jose Velez, Joseph E Duran, Joy Rkozlowski Klena, Juan Rjimenez Garcia, Juanita P Versace, Julianne C Mccullough, Julie D Bringger, Junho Pak, Justin A Boyd, Justine Tomasso, Karen A Briggs, Karen A Wolnik, Karen C Daugherty, Karen M Rodriguez, Kari M Johansen, Kari M Laynor, Karl D Hezel, Katherine D Adams, Katherine Szestypalow, Kathy E Noe, Kejun Cheng, Kellia N Hicks, Kenneth H Williams, Kent C Faul, Kevin A Gonzalez, Kevin P Regan, Kham Phommachanh, Krishna Ghosh, PhD, Kristen D Evans, Kristy A Zielny, Laiza V Garcia, Lance Mde Souza, MBA, Lance Sindo, CIH, CQA, RS, Lane V Christensen, PhD, Lareese K Thomas, Larry K Austin, Lata C Mathew, PhD, Latorie S Jones, Laura E Garcia, Laurie B Frazier, Laurimer Kuilan Torres, Lawrence Harmon, Jr, LCDR Debra Emerson, LCDR Jennifer H Rhyu, LCDR Michael H Tollon, Lei Zhang, PhD, Leiyun Boone, PhD, Leonard H Lavi, Lequita M Mayhew, Libia M Lugo, Linda F Murphy, Linda Thai, Lindsey M Schwierjohann, Lisa M Lopez, Lisa R Hilliar, Lisa R Jennings, Lisa R Whitt, Lisa Shin, Lizaida E Rodriguez, Logan T Williams, Loreily Figueroa Agrinsoni, Lourdes Andujar, Lourdes Valentin Aponte, LT Kimberly M Hull, LT Luis O Rodriguez, LT Rafael Gonzalez, LT Tamara J Henderson, Lucas B Leake, Luella J Rossi, Luis A Carrion, Luis A Dasta, Luis Mburgos Medero, Madushini Dharmasena, PhD, Mahesh Ramanadham, Makini Cobourne Duval, PhD, Marcellinus D Dordunoo, Marcus A Ray, Margaret M Annes, Margaret M Sands, Margarita Santiago, Maria A Ruttell, Maria Gutierrez Lugo, PhD, Maria Joselopez Barragan, PhD, Maria Pkelly Doggett, MBA, Marian E Ramirez, Marianela Aponte Cruz, Maribel V Juarbe, Maridalia Torres Irizarry, Marie B Buen Bigornia, Marie T Falcone, Marijo B Kambere, PhD, Marilyn Santiago, Mark R Mcclain, Marta E Gonzalez, Marvin D Jones, Mary E Storch, Mary L Schuckmann, Maryam Tabatabaie, Marybet Lopez Negron, Massoud Motamed, Matthew B Casale, Matthew R Dionne, Maxwell Van Tassell, PhD, Medina, Megan A Haggerty, Meisha R Sampson, Meisha Waters, Melba Trivera Clavell, Melissa J Garcia, Melissa M Steiger, Mendoza, Michael A Charles, Michael C Zubelewicz, Michael E Maselli, Michael J Kuchta, Michael L Chasey, Michael Levy, Michael R Goga, Michael R Klapal, Michael Shanks, MS, Michael Y Philopoulos, Michele L Glendenning, Michele L Obert, Michele Perry Williams, Michelle Yclark Stuart, Miguel A Martinez Perez, Miguel Hernandez Sanchez, Mihaly S Ligmond, Milva E Melendez Perales, Min Tang, Mizanne E Lewis, Monica Cburgos Garcia, Monica M Mcclure, Moraima Jramos Valle, Mra B Kamberem, Mra Davism, Mra Mcculloughj, Mra Munizn, Muralidhara B Gavini, PhD, Myriam M Sosa, Nadeem I Chaudhry, Nancy A Bellamy, Nancy M Espinal, Nancy Rosado, Navista C Bolton, Nealie C Newberger, Nebil A Oumer, Neil J Bonzagni, PhD MPH, Neisa M Alonso, Nicholas A Violand, Nicholas L Paulin, Nicholas Obiri, PhD, Nicole E Knowlton, Niketa Patel, Nikolay Spiridonov, Noreen Muñiz, Nydia E Colon, Omotunde O Osunsanmi, Pablo Feliciano, Pal S Mayasandra, Pankaj H Amin, Paraluman S Leonin, Parul M Patel, Patricia F Hughes, PhD, Patricia H Dlugosz, Patrick C Klotzbuecher, Patsy J Domingo, Patty P Kaewussdangkul, Paul A Bonneau, Paul L Bellamy, Paul L Figarole, Jr, Paul Mouris, Paul Z Balcer, Paula A Trost, Paula J Perry, Penny H Mccarver, Peter E Baker, Prabhu P Raju, Pratik S Upadhyay, DDC, Qiao Y Bobo, Qin Xu, Rachel C Harrington, Rafael E Arroyo, Rafael E Cruz, Rafael Nevarez Nieves, Rafael Padilla, Rafeeq A Habeeb, Rajiv R Srivastava, Rakhi B Shah, Ralph H Vocque, Ramesh Potla, PhD, Ramon A Hernandez, Randy L Self, Rapti D Madurawe, Raquel Gonzalez Rivera, Reba A Gates, Rebeca M Melendez, Rebecca E Dombrowski, Rebecca Parrilla, Rebecca Rodriguez, Regina T Brown, Reyes Candau Chacon, PhD, Richard E Needham, Richard G Fochesato, Richard L Friedman, Richard Ledwidge (nmi), PhD, Riley C Myers, PhD, Rita K Kabaso, Robert C Coleman, Robert C Steyert, Robert D Tollefsen, Robert Darius, Robert J Ham, Robert J Martin, Robert M Barbosa, Robert Sharpnack, Rochelle K Kimmel, Rochelle L Cross, Roger F Zabinski, Ronald G Crawford, Rong Guo, Rosa J Motta, Rose Ashley, Roy R Rinc, Rumany C Penn, PharmD, Russ E Davis, Russell J Glapion, Russell K Riley, S Lori Brown, PhD MPH, Saied A Asbagh, Saleem A Akhtar, Salvatore N Randazzo, Samina S Khan, Sandra A Hughes, Sangeeta M Khurana, PhD, Santos E Camara, Sarah E Mcmullen, Sarah Ibrahim, Satheesh Thomas, Scott B Laufenberg, Scott T Ballard, Sean R Marcsisin, Seneca D Toms, Sharmista Chatterjee, Sharon K Thoma, PharmD, Shawn E Larson, Shawn Gould, Shelby N Turner, Shelly A Rios Laluz, Shirley J Berryman, Sidney B Priesmeyer, Simone E Pitts, Sixto M Mercado Rios, Sonia M Monges, Sony Mathews, Sripal R Mada, PhD, Stacey S Degarmo, Stacie A Woods, Stephanie A Slater, MS, Stephanie D Crockett, Stephanie Mangigian, MS/OSH, RN, Stephen D Brown, Stephen J Mottola, Stephen L Beekman, Steven A Brettler, Steven B Barber, Steven C Madzo, Steven D Dittert, Steven D Kehoe, Steven E Bowen, PhD, Steven Fong, MS, PhD, Steven M Weinman, Steven P Donald, Sumit Sen, Susan D Yuscius, Susan F Laska, MS, Susan M Jackson, Susan P Bruederle, Susan T Hadman, Susanna E Ford, Susanne M Richardson, MS RAC, Suzanne N Vallez, Tajah L Blackburn, Tamil Arasu, PhD, Ted L Anderson, Temar Q Williams, Teresa I Navas, Terri L Dodds, Thomas J Arista, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Timothy T Kapsala, Timothy Wadkin, PhD, Tomika L Bivens, Tonia F Bernard, Tonnie L Carter, Torrance J Slayton, Toyin B Oladimeji, Tracey L Harris, Tricia S Martinez, Tricia Y Samaniego, Uduak M Inokon, Uttaniti Limchumroon (Tom), Vidya B Pai, Vilmary Negron Rodriguez, Vincent Thomas, Virgilio F Pacio, CSO, Vlada Matusovsky, Walden H Lee, Wanda J Torres, Wayne D Mcgrath, Wayne E Seifert, Wen Ning Chan (Sally), Wendy G Tan, PhD, William A Warnick, William Hallett, PhD, William J Leonard, Xiaokuang Lai, PhD, Xikui Chen (nmi), PhD, Xiujing L Baggett, Yasamin Ameri, Yeissa Chabrier Rosello, Yetao Jin, PhD, Yifan Wang, Ying Zhang, Youkeun Kim, Youmin Wang, Yumi J Hiramine, Yvesna C Blaise, Yvette I Henry, Yvette I Johnson, Yvins Dezan, Yvonne C Mcknight, Zachary A Bogorad, Zachary L Miller, Zachary L Stamm, Zhao Wang, PhD, Zhong Li, PhD, Ziyang Su, PhD, Zonglin Hu

José E Meléndez's Documents

Publish Date Document Type Title
February, 2001 FDA 483 Response Schering Plough Products, LLC - Form 483R, 2001-08-18
June, 2012 FDA 483 Auro PR Inc. - Form 483, 2012-06-07
June, 2018 FDA 483 Glaxo Wellcome Manufacturing Pte. Ltd - Form 483, 2018-06-01
April, 2018 FDA 483 Mylan Laboratories Limited - Form 483, 2018-04-12
August, 2013 EIR Amgen Manufacturing Limited LLC - EIR, 2013-08-15
August, 2003 FDA 483 Syntex Puerto Rico, Inc. - Form 483, 2003-08-29
April, 2008 FDA 483 Smithkline Beecham (Cork) Inc. - Form 483, 2008-04-18
May, 2007 FDA 483 Galephar Pharmaceutical Research Inc - Form 483, 2007-05-08
October, 2023 FDA 483 AbbVie Biotechnology LTD - Form 483, 2023-10-30
February, 2017 EIR MIPHARM SPA - EIR, 2017-02-03
September, 2011 FDA 483 Pfizer Pharmaceuticals LLC - Form 483, 2011-11-01
August, 2003 EIR Syntex Puerto Rico, Inc. - EIR, 2003-08-29
May, 2009 FDA 483 TAPI Puerto Rico, Inc. - Form 483, 2009-05-19
July, 2021 FDA 483 YUKI GOSEI KOGYO CO., LTD. - Form 483, 2021-07-28
July, 2021 FDA 483 Takeda Pharmaceutical Company Limited - Form 483, 2021-07-19
April, 2009 FDA 483 Patheon Puerto Rico, Inc. - Form 483, 2009-04-08
April, 2019 FDA 483 Response Amgen Manufacturing Limited LLC - Form 483R, 2019-04-29
April, 2019 FDA 483 Amgen Manufacturing Limited LLC - Form 483, 2019-04-11
June, 2009 FDA 483 Janssen-Cilag Manufacturing, LLC - Form 483, 2009-06-08
March, 2007 FDA 483 Wyeth Pharmaceuticals Company - Form 483, 2007-03-27
April, 2011 FDA 483 MSD International GMBH Puerto Rico Branch LLC - Form 483, 2011-04-14
March, 2011 FDA 483 Allergan Sales, LLC - Form 483, 2011-03-25
June, 2006 FDA 483 INyX USA, Ltd. - Form 483, 2006-06-09
December, 2019 FDA 483 Sun Pharmaceutical Industries Limited - Form 483, 2019-12-13
February, 2020 FDA 483 SHILPA MEDICARE LIMITED - Form 483, 2020-02-25
April, 2005 FDA 483 CEPH International Corporation - Form 483, 2005-04-22
May, 2015 FDA 483 Baxter Healthcare Corporation - Form 483, 2015-05-01
May, 2018 FDA 483 New Zealand Pharmaceuticals Limited - Form 483, 2018-05-25
April, 2017 FDA 483 Fresenius Kabi Oncology Limited - Form 483, 2017-04-14
August, 2017 EIR Industriale Chimica s.r.l. - EIR, 2017-08-04
December, 2005 FDA 483 Wyeth Pharmaceuticals Company - Form 483, 2005-12-15
November, 2011 FDA 483 Baxter Healthcare Corporation - Form 483, 2011-11-03
August, 2018 FDA 483 INOVAT Industria Farmaceutica LTDA. - Form 483, 2018-08-14
February, 2020 FDA 483 LUPIN LIMITED - Form 483, 2020-02-11
December, 2022 FDA 483 Strides Pharma Science Limited - Form 483, 2022-12-09
March, 2021 FDA 483 McNeil Healthcare LLC. - Form 483, 2021-03-31
February, 2005 FDA 483 McNeil Healthcare LLC. - Form 483, 2005-02-23
June, 2016 FDA 483 Fermion Oy - Form 483, 2016-06-03
June, 2018 FDA 483 MSD International GmbH (Singapore Branch) - Form 483, 2018-06-08
February, 2013 FDA 483 Lee & Company - Form 483, 2013-02-21
February, 2008 FDA 483 Janssen Ortho LLC - Form 483, 2008-02-21
May, 2008 FDA 483 Pfizer Pharmaceuticals LLC-Piperacillin - Form 483, 2008-05-28
December, 2018 FDA 483 Response Baxter Healthcare Corporation - Form 483R, 2019-01-16
April, 2004 EIR Pfizer Pharmaceuticals LLC - EIR, 2004-04-14
February, 2017 EIR F.I.S. FABBRICA ITALIANA SINTETICI S.P.A. - EIR, 2017-02-17
September, 2022 FDA 483 Torrent Pharmaceuticals Limited - Form 483, 2022-09-28
April, 2006 EIR McNeil Healthcare LLC. - EIR, 2006-04-07
October, 2018 FDA 483 Response Dr Reddy's Laboratories Limited - Form 483R, 2018-11-20
September, 2021 EIR Zoetis Belgium S.a. - EIR, 2021-09-28
February, 2010 FDA 483 Xellia Pharmaceuticals ApS - Form 483, 2010-02-11
February, 2005 EIR McNeil Healthcare LLC. - EIR, 2005-02-23
August, 2009 FDA 483 Dharma Research, Inc. - Form 483, 2009-08-28
May, 2003 EIR Cardinal Health Manufacturing Services B.V. - EIR, 2003-05-08
December, 2005 EIR PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC - EIR, 2005-12-15
October, 2018 FDA 483 Dr Reddy's Laboratories Limited - Form 483, 2018-10-30
December, 2017 FDA 483 Otsuka Pharmaceutical Co Ltd - Form 483, 2017-12-08
March, 2024 FDA 483 Boehringer Ingelheim Animal Health Puerto Rico LLC - Form 483, 2024-03-27
April, 2019 EIR Amgen Manufacturing Limited LLC - EIR, 2019-04-11
February, 2019 FDA 483 Emcure Pharmaceuticals Limited - Form 483, 2019-02-20
June, 2017 FDA 483 Labocont Industrial SRL - Form 483, 2017-06-09
April, 2004 FDA 483 Pfizer Pharmaceuticals LLC - Form 483, 2004-04-14
September, 2015 FDA 483 Patheon Puerto Rico, Inc. - Form 483, 2015-09-03
June, 2003 EIR Mylan Inc. - EIR, 2003-06-16
August, 2013 FDA 483 Amgen Manufacturing Limited LLC - Form 483, 2013-08-15
August, 2003 FDA 483 Legacy Pharmaceuticals Puerto Rico, LLC - Form 483, 2003-08-29
November, 2021 FDA 483 Janssen-Cilag Manufacturing, LLC - Form 483, 2021-11-23
June, 2012 EIR Auro PR Inc. - EIR, 2012-06-07
March, 2000 FDA 483 Schering-Plough Products LLC - Form 483, 2000-03-28
April, 2004 FDA 483 Response Pfizer Pharmaceuticals LLC - Form 483R, 2004-05-10
December, 2016 FDA 483 Bridgewest Perth Pharma Pty Ltd - Form 483, 2016-12-13
April, 2002 EIR TAPI Puerto Rico, Inc. - EIR, 2002-04-11
October, 2008 FDA 483 IPR Pharmaceuticals, Inc - Form 483, 2008-10-27
March, 2015 FDA 483 Teva Puerto Rico LLC - Form 483, 2015-03-06
March, 2010 FDA 483 Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company - Form 483, 2010-03-31
May, 2022 FDA 483 Mylan Laboratories Limited - Form 483, 2022-05-27
December, 2017 FDA 483 Kyongbo Pharmaceutical Co., Ltd. - Form 483, 2017-12-01
May, 2003 FDA 483 Cardinal Health Manufacturing Services B.V. - Form 483, 2003-05-08
September, 2019 FDA 483 Pfizer Healthcare India Private Limited - Form 483, 2019-10-17
August, 2016 FDA 483 Qilu Pharmaceutical (Hainan) Co., Ltd. - Form 483, 2016-08-02
August, 2003 FDA 483 Syntex PR, Inc. - Form 483, 2003-08-29
April, 2016 FDA 483 Mylan Laboratories Limited - Form 483, 2016-04-13
June, 2017 FDA 483 Laboratorio Magnachem International SRL - Form 483, 2017-06-02
November, 2021 FDA 483 Response Janssen-Cilag Manufacturing, LLC - Form 483R, 2021-12-15
February, 2002 EIR Bristol-Myers Squibb Manufacturing Company Unlimited Company - EIR, 2002-02-28
December, 2018 EIR Baxter Healthcare Corporation - EIR, 2018-12-21
October, 2019 FDA 483 Mylan Laboratories Limited - Form 483, 2019-10-25
July, 2010 FDA 483 Bora Pharmaceutical Services Inc - Form 483, 2010-07-16
September, 2009 FDA 483 Amgen Manufacturing Limited LLC - Form 483, 2009-09-11
December, 2019 FDA 483 ZENARA PHARMA PRIVATE LIMITED - Form 483, 2019-12-20
August, 2018 EIR INOVAT Industria Farmaceutica LTDA. - EIR, 2018-08-14
February, 2017 FDA 483 MIPHARM SPA - Form 483, 2017-02-03
August, 2017 FDA 483 Industriale Chimica s.r.l. - Form 483, 2017-08-04
September, 2011 EIR Pfizer Pharmaceuticals LLC - EIR, 2011-09-01
December, 2022 FDA 483 Intas Pharmaceuticals Limited - Form 483, 2022-12-02
April, 2002 FDA 483 TAPI Puerto Rico, Inc. - Form 483, 2002-04-11
December, 2015 FDA 483 AGC Inc. - Form 483, 2015-12-04
September, 2022 FDA 483 Torrent Pharmaceuticals Limited - Form 483, 2022-09-28
December, 2018 FDA 483 Baxter Healthcare Corporation - Form 483, 2018-12-21
March, 2011 FDA 483 PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC - Form 483, 2011-03-08
December, 2016 FDA 483 South Pacific Sera Limited - Form 483, 2016-12-01
February, 2023 FDA 483 Cipla Ltd. - Form 483, 2023-02-17
June, 2006 EIR INyX USA, Ltd. - EIR, 2006-06-09
April, 2018 FDA 483 GLAND CHEMICALS PRIVATE LIMITED - Form 483, 2018-04-03
July, 2021 EIR YUKI GOSEI KOGYO CO., LTD. - EIR, 2021-07-28
December, 2009 FDA 483 Wyeth Pharmaceuticals Company - Form 483, 2009-12-11
May, 2022 FDA 483 BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED - Form 483, 2022-05-17
February, 2024 FDA 483 Lilly del Caribe, Inc. - Form 483, 2024-02-16
October, 2010 FDA 483 Amgen Manufacturing Limited LLC - Form 483, 2010-10-01
September, 2023 FDA 483 McNeil Healthcare LLC. - Form 483, 2023-09-20
March, 2019 FDA 483 EUGIA SEZ PRIVATE LIMITED - Form 483, 2019-03-01
June, 2006 FDA 483 Warner Chilcott Company, LLC - Form 483, 2006-06-23
August, 2018 FDA 483 Gador SA - Form 483, 2018-08-03
December, 2013 FDA 483 Pharmalogic Puerto Rico, Inc. - Form 483, 2013-12-27
February, 2001 FDA 483 Schering-Plough Products LLC - Form 483, 2001-02-16
November, 2021 EIR Janssen-Cilag Manufacturing, LLC - EIR, 2021-11-23
October, 2013 EIR Frontage Laboratories (Shanghai) Co., Ltd. - EIR, 2013-10-30
March, 2010 FDA 483 Response Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company - Form 483R, 2010-04-14
October, 2018 EIR Dr Reddy's Laboratories Limited - EIR, 2018-10-30
March, 2011 EIR Allergan Sales, LLC - EIR, 2011-03-25
May, 2005 EIR Janssen Ortho LLC - EIR, 2005-05-23
September, 2022 FDA 483 Tianish Laboratories Private Limited - Form 483, 2022-09-17
February, 2018 FDA 483 BIOCON SDN.BHD. - Form 483, 2018-02-15
July, 2019 FDA 483 Lilly del Caribe, Inc. - Form 483, 2019-07-12
August, 2019 FDA 483 Mylan Laboratories Limited - Form 483, 2019-08-27
June, 2015 FDA 483 Zhejiang Tianyu Pharmaceutical Co., Ltd. - Form 483, 2015-06-12
November, 2014 FDA 483 TAPI Puerto Rico, Inc. - Form 483, 2014-11-17
December, 2012 FDA 483 INOVAT Industria Farmaceutica LTDA. - Form 483, 2012-12-11
February, 2016 FDA 483 FARMAK, a..s. - Form 483, 2016-02-12
September, 2005 EIR CATALENT PR HUMACAO, INC./dba CATALENT PHARMA SOLUTIONS, LLC - EIR, 2005-09-20
May, 2024 FDA 483 Sterling Pharmaceutical Services, LLC - Form 483, 2024-05-01

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