FDA Investigator Dr. Robert C Horan, MD

Dr. Robert C Horan, MD has inspections in 11 countries as of 01 Nov 2023. Dr. Robert C Horan, MD has collaborated with a combinined 8774 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
233
Last Inspection Date:
01 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, China, Japan, India, Germany, Korea (Republic of), United Kingdom of Great Britain and Northern Ireland, Switzerland, Singapore, Australia
Co-Investigator(s):
Ademola O Daramola, Adetutu M Gidado, Aditi S Thakur, Alan P Kurtzberg, Alberto A Viciedo, Albinus D'sa, PhD, Albinus M D Sa, Alia Legaux, Alice S Tsao, Alicia M Mozzachio, Althea A Williams, Amatul H Marium, Amy W Yan Mai, Anastasia M Shields, Andrew J Garufi, Andrew M Abramowitz, Angela E Glenn, Angela Jourdain, Angela R Jourdain, Anh M Lac, Ann B Okon, Ann L Demarco, Ann M Stewart, Ann Marie Montemurro, Ann Marie Schofield, Anna M Brannen, Annemarie Bodnar, Anthony C Warchut, Anthony Kovalenko, Arduino Frankovic, Arsen Karapetyan, Arthur G Hurst, Atul J Agrawal, Avital A Shimanovich, Azza Talaat, Barbara J Wilimczyk, Barbara Jwilimczyk Macri, Barbara M Frazier, Bijoy Panicker, Bo Chi, PhD, Bonita S Chester, Brandy N Lepage, Brenda W Uratani, PhD, Brian J Ryan, Brooke K Higgins, Bruce G Cooper, Burnell M Henry, Byungja E Marciante, Candace Gomez Broughton, PhD, Candace Y Gomez Broughton, Candido Torres, Carl Lee, Carlos Chavez, Carolina D Vasquez, Caryn M Mcnab, CDR Ileana Barreto Pettit, CDR Rochelle B Young, RPh, MSA, Charanjeet Jassal, Charisse K Green, Charles I Ann, Charles L Zhou, Charles M Edwards, Charles R Cote, RIC, Charlotte Hinkle, Cheryl A Clausen, Chiang Syin, PhD, Christian D Lynch (CDL), Christian Parra, Christina A Miller, Christina V Santos, Christine M Rivera, Christopher S Fields, Christopher S Keating, Christopher T Middendorf, Colin E Tack, Concepcion Cruz, Jr, Cynthia J Lee, MS, Cynthia Jim, CSO, Cynthia Whitmarsh, D Jennyxirakis Xiradakis, Daniel J Grabicki, Daniel J Roberts, Daniel L Zheng, Danna E Solorzano, Darin S Wiegers, David G Eng, David M Beltran, David R Delucia, David S Jackson, Deborah J Parris, Dell S Moller, Demitria J Argiropoulos, Demitria J Xiradakis, Dennis Cantellops Paite, Dennis E Guilfoyle, PhD, Devaughn Edwards, Dhanalakshm Kasi, Dilijeta Bajrami, Dipesh K Shah, Doan T Nguyen, PharmD, Donald C Obenhuber, PhD, Donald G Gordon, Donald L Lech, Dongping Dai, PhD, Douglas G Ng, Dr. Carmelo Rosa, Dr. Gang Wang, PhD, Dr. S Nar Ali, PhD, Edecia A Richards, Edmund F Mrak, Jr, Edouard Viard, Ellen C Weisensel, Ellen P Madigan, Erica B Raphael, Erik W Koester, Erika E Englund, PhD, Erika V Butler, Erin L Nagel, Farhana Khan, Feiyan Jin, Felix Maldonado, Francis A Guidry, Frank Verni, Frederick Razzaghi, Gam S Zamil, Ganesh N Joshi, Gary J Hagan, Gary J Lader, Gary J Lehr, Gary T Greco, Gayle S Lawson, George J Flynn, Grace E Mcnally, Guerlain Ulysse, Guo Q Shen, Gwyn G Dickinson, Hamet M Toure, PharmD MPH, Harry J Brewer, Helen B Ricalde, Helen Verdel, Ilana Zigelman, Iram R Hassan, PhD, Irina Gaberman, Ivis Lnegron Torres, J Paul Kirwan, PhD, Jacek Cieslak, PhD, Jacqueline Mdiaz Albertini, Jacqueline S Warner, Jaison J Eapen, James A Liubicich, James C Maclaughlin, James D Bridges, James I Giefer, James L Dunnie, Jr, James M Mason, James P Mcreavey, James R Birkenstamm, Jason D Tenney, Javier O Vega, Jawaid Hamid, Jay Slater, MD, Jay T Wong, Jazmine N Brown, Jazmine N Still, Jeffery A Hangartner, Jeffrey D Meng, Jeffrey P Raimondi, Jennifer L Bridgewater, Jens Fricke, Jogy George, John A Gonzalez, John A Podsadowski, John D White, John M Dietrick, John P Mistler, John S Hartford, Johnna L Bleem, Jonah S Ufferfilge, Jonathan G Matrisciano, Jorge L Gonzalez, Jorge L Guadalupe, Jose Acruz Gonzalez, Jose Alopez Rubet, Jose E Melendez, DDC, Jose M Cayuela, Jose O Hernandez, Jose Ohernandez Guzman, Jose R Hernandez, Joseph F Mcginnis, RPh, Joseph J Vannelli, Joseph Maselli, Joseph Mcginnis, Joy P Matthias, Joy Rkozlowski Klena, Juan Rjimenez Garcia, Juanita P Versace, Julie D Bringger, June P Page, Justin A Boyd, Justine M Corson, Justine Tomasso, Kalavati Suvarna, PhD, Karen K Moksnes, Karen L Kosar, Karen Takahashi, Karishma G Gopaul, Karl Auguste, Katherine Szestypalow, Kathryn A Nagy, Kazi Rafiquzzaman, Kenneth G Klobus, Kenneth H Williams, Kent C Faul, Kevin A Gonzalez, Kevin D Kallander, Kevin J Flessa, Kevin P Foley, Kham Phommachanh, Khoa Nathanv Tran, Kim Lthomas Cruse, Kim M Downing, Kim Thomasc Rice, Kimberley A Hoefen, Kimberley A Ricketts, Kimberly Y Smithson, Ko U Min, Kristen D Evans, Kumar G Janoria, Kwong P Lee, L Norwood, Lakshmi Narasimhan, PhD, Larry K Austin, Lata C Mathew, PhD, Latorie S Jones, Laura Fontan, MS, Laurie Graham, Lawrence W Farina, LCDR Chad N Thompson, LCDR Debra Emerson, Leonard H Lavi, Li Yun Huang, Liatte Kreuger, PharmD, Linda M Sacco, Lisa R Hilliar, Lori A Holmquist, Lucas B Leake, Luis A Dasta, Lynda L Perry, PhD, M Pedgen, Mamta Gautam Basak, PhD, Manhar R Patel, Maotang Zhou, PhD, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marcia D Fields, Margaret E Sarles, Margaret M Annes, Margaret M Sands, Maria Joselopez Barragan, PhD, Marie Bbuen Bigornia, Marie F Morin, Marijo B Kambere, PhD, Mariza M Jafary, Mark R Mcclain, Marlene G Swider, Marshalette O Edwards, Mary F Finn, Mary Jeanet Mcgarry, Mary M Finn, Matthew A Spataro, Matthew B Casale, Matthew C Watson, Matthew D Schnittker, Matthew J Johnson, Maxwell Van Tassell, PhD, Megan A Haggerty, Meisha R Sampson, Meisha Waters, Meredith P Soehl, Investigator, Michael A Charles, Michael A Taylor, Michael E Maselli, Michael L Chasey, Michael Levin, Michael R Goga, Michael R Klapal, Michael W Burd, Michele L Glendenning, Michele L Obert, Michele Perry Williams, Michelle D Haamid, Michelle Y Clark Stuart, Miguel A Martinez, Mihaly S Ligmond, Milos Dokmanovic, PhD, Mindy M Chou, Miral B Patel, Mra Davism, Mra Digiuliod, Mra M Barbosar, Mra Mcculloughj, Muna Algharibeh, Muralidhara B Gavini, PhD, Nancy M Espinal, Nariman Patenaude, Natasha Gupta, Nazmul Hassan, Nealie C Newberger, Neil J Bonzagni, PhD MPH, Nerizza B Guerin, Nicholas A Violand, Nicholas C Mendiola, Nicole E Knowlton, Nije A Thomas, Noreen Muniz, Obinna R Echeozo, Omadevi Somai, Investigator, Omotunde O Osunsanmi, Otto D Vitillo, Pankaj H Amin, Paraluman S Leonin, Parul M Patel, Patricia F Hughes, PhD, Patricia Fhughes Troost, Patrick C Klotzbuecher, Paul E Stein, Paul L Bellamy, Paul Mouris, Paula A Trost, Paula J Bretz, Pete Amin (Pankaj), Peter Abel, Peter Caparelli, Peter E Baker, Peter R Caparelli, Peter S Diak, Philip F Istafanos, DMV, MS, Phyllis J Wilson, Prabhu P Raju, Pratik S Upadhyay, DDC, Preston M Lee, Rachael A Moliver, Rachael L Cook, Rajiv R Srivastava, Ramon A Hernandez, Ramon E Martinez, Ranjani Prabhakara, Raquel Gonzalez Rivera, Rashmi Rawat, PhD, Reba A Gates, Regina T Brown, Reyes Candau Chacon, PhD, Richard A Abate, Richard E Needham, Richard Ferfoglia, Richard H Penta, Richard J Friedman, Richard L Rutherford, Richard Ledwidge (nmi), PhD, Richard Needman, Richard W Thornton, Rita K Kabaso, Rober C Horan, PhD, Robert C Henry, Robert C Horu, PhD, Robert C Howard, Robert C Steyert, Robert D Tollefsen, Robert J Martin, Robert J Veitch, Robert Mo Brien, Rochelle K Kimmel, Rochelle L Cross, Roger F Zabinski, Ronald Ifraimov, Rory K Geyer, Rose Ashley, Rose M Ashley, Rose Xu, Roseline N Boateng, Russ E Davis, Russell J Glapion, Russell K Riley, Samina S Khan, Samuel K Mathew, Samuel T Walker, Sandra A Boyd, Sandra A Hughes, Sangeeta M Khurana, PhD, Sarah A Meehan, Sarah A Wangseng, Sarah E Mcmullen, Sarah Kennett, PhD, Satheesh Thomas, Sathesssh Thomas, Saundrea A Munroe, Sayyem H Akbar, Scott B Laufenberg, Scott R Nichols, PhD, Scott T Ballard, Sean R Marcsisin, Shari L Kahn, Sharon K Thoma, PharmD, Shelby N Marler, Shirley S Wen, Sidney B Priesmeyer, Simone E Pitts, Sixto M Mercado Rios, Sony Mathews, Srinivas R Chennamaneni, PhD, Sripal R Mada, PhD, Stacey S Degarmo, Stephanie A Slater, MS, Stephanie T Durso, Stephen D Brown, Steven D Kehoe, Steven J Libal, Steven M Weinman, Sumit Sen, Sunita Vij, Susan M Jackson, Susan M Joseph, Susan W Ting, Susan Zang, Susanna E Ford, Analyst, Susant Hadman, Suwaskie S Smith, Syed N Ali, Syeda N Mahazabin, Taichun Qin, PhD, Tamil Arasu, PhD, Tammy Notto, Tammy S Notto, Tanya R Syffrard, Tara K Carmody, Tara K Normandin, Ted L Anderson, Teresa I Navas, Terry Bridgewater, Thomas E Friel, Thomas J Arista, Thomas J Mccrey, Thomas J Mooney, Thomas P Hansen, Thomas R Withers, Thomas Ryan Withers, Thomas S Arista, Thomas S Savage, Thuy T Nguyen, LCDR, Tiara M Brown, Timothy T Kapsala, Torrance J Slayton, Tracey L Harris, Tracy M Portelli, Tricia S Martinez, Tsedenia Woldehanna, Tyanna N Hadley, Tzanko Stantchev, Uduak M Inokon, Unnee Ranjan, Uttaniti Limchumroon (Tom), Valentino Fiorella, Valerie A Potopsingh, Vilmary Negron Rodriguez, Vivin George, Walden H Lee, Wayne D Mcgrath, Wayne E Seifert, Wayne S Fortenberry, Wayne T Smith, Wendy G Tan, PhD, William A Warnick, William J Leonard, William M Rennells, Willie Wilson, Xikui Chen (nmi), PhD, Yasamin Ameri, Yuyan Liang, Yvesna C Blaise, Yvette I Johnson, Yvins Dezan, Zachary A Bogorad, Ze Peng, Zhongren Wu, Zi Qiang Gu

Dr. Robert C Horan, MD's Documents

Publish Date Document Type Title
October, 2010 FDA 483 Response American Regent, Inc. - Form 483R, 2010-11-19
June, 2011 FDA 483 MANA PRODUCTS, INC. - Form 483, 2011-06-23
October, 2002 FDA 483 Response Sichuan Long March Pharmaceutical Co. Ltd. - Form 483R, 2002-11-20
October, 2003 FDA 483 Response Shanghai Medicinal Ltd. No. 15 Pharmaceutical Factory - Form 483R, 2003-11-10
April, 2002 EIR American Regent, Inc. - EIR, 2002-04-30
November, 2000 FDA 483 Response Sun Pharmaceutical Industries Limited - Form 483R, 2000-11-28
December, 2011 FDA 483 Advance Pharmaceutical, Inc. - Form 483, 2011-12-16
May, 2001 EIR MSD International GmbH (Singapore Branch) - EIR, 2001-07-13
June, 2015 FDA 483 Biogen, Inc. - Form 483, 2015-06-26
May, 2002 FDA 483 Response United Pet Group, Inc. - Form 483R, 2002-06-04
February, 2007 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2007-02-07
December, 2007 FDA 483 DPT Lakewood, Inc. - Form 483, 2007-12-05
March, 2002 FDA 483 Response Bayer AG - Form 483R, 2002-04-19
May, 2001 EIR KAKEN Pharmaceutical Co., LTD - EIR, 2001-07-11
December, 2001 FDA 483 Jetpharma SA - Form 483, 2001-12-06
July, 2010 FDA 483 Qilu Pharmaceutical Co., Ltd. - Form 483, 2010-07-01
December, 2015 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2015-12-15
August, 2007 FDA 483 American Regent, Inc. - Form 483, 2007-08-03
June, 2000 FDA 483 American Regent, Inc. - Form 483, 2000-06-16
May, 2001 FDA 483 KAKEN Pharmaceutical Co., LTD - Form 483, 2001-05-18
December, 2017 FDA 483 Kreitchman PET Center - Form 483, 2017-12-15
August, 2007 FDA 483 Response American Regent, Inc. - Form 483R, 2007-08-17
April, 2017 FDA 483 Bristol-Myers Squibb Company - Form 483, 2017-04-28
October, 2002 FDA 483 Shanghai Medicinal Ltd. No. 15 Pharm Fact. - Form 483, 2002-10-17
April, 2017 FDA 483 Amneal Pharmaceuticals of New York, LLC - Form 483, 2017-04-11
July, 2017 FDA 483 Advance Pharmaceutical, Inc. - Form 483, 2017-07-06
June, 2006 FDA 483 Generic Pharmaceutical Services inc. - Form 483, 2006-06-29
May, 1998 FDA 483 TIME CAP LABORATORIES, INC - Form 483, 1998-05-05
October, 2000 FDA 483 Response Sun Pharmaceutical Industries Limited - Form 483R, 2000-12-04
October, 2012 FDA 483 Busse Hospital Disposables, Inc. - Form 483, 2012-10-25
June, 2014 FDA 483 Regeneron Pharmaceuticals, Inc. - Form 483, 2014-06-13
June, 2001 FDA 483 Response Zhejiang Kangle Pharmaceutical Co., Ltd. - Form 483R, 2001-06-12
September, 2000 EIR Chartwell Pharmaceuticals Amityville, LLC. - EIR, 2000-09-05
March, 2001 FDA 483 Response Fougera Pharmaceuticals Inc. - Form 483R, 2001-04-03
November, 2010 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2010-11-19
June, 2000 FDA 483 Response American Regent, Inc. - Form 483R, 2000-06-30
December, 2013 FDA 483 Advance Pharmaceutical, Inc. - Form 483, 2013-12-19
November, 2000 FDA 483 Response Dr. Reddy's Laboratories Limited - Form 483R, 2000-11-23
January, 2018 FDA 483 Amneal Pharmaceuticals of New York, LLC - Form 483, 2018-01-18
October, 2003 EIR Shanghai Medicinal Ltd. No. 15 Pharmaceutical Factory - EIR, 2003-12-09
May, 2001 FDA 483 Response Fougera Pharmaceuticals Inc. - Form 483R, 2001-05-08
October, 2000 EIR Sun Pharmaceutical Industries Limited - EIR, 2000-10-27
February, 2015 FDA 483 Lonza Biologics, Inc. - Form 483, 2015-02-10
April, 2008 FDA 483 Bristol-Myers Squibb Co., Inc. - Form 483, 2008-04-18
August, 2013 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2013-08-08
November, 2010 FDA 483 Chartwell Pharmaceuticals Amityville, LLC. - Form 483, 2010-11-12
July, 2014 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2014-07-29
June, 2006 EIR American Regent, Inc. - EIR, 2006-06-16
May, 2015 FDA 483 InvaGen Pharmaceuticals, Inc - Form 483, 2015-05-26
March, 2002 FDA 483 Bayer AG - Form 483, 2002-03-20
April, 2009 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2009-04-28
October, 2000 FDA 483 Sun Pharmaceutical Industries Limited - Form 483, 2000-10-27
June, 2006 FDA 483 American Regent, Inc. - Form 483, 2006-06-16
March, 2003 FDA 483 LUPIN LIMITED - Form 483, 2003-03-24
August, 2016 FDA 483 Response Regeneron Pharmaceuticals, Inc. - Form 483R, 2016-09-08
October, 2000 FDA 483 Sun Pharmaceutical Industries Limited - Form 483, 2000-10-20
March, 2012 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2012-03-19
October, 2002 EIR Sichuan Long March Pharmaceutical Co. Ltd. - EIR, 2002-10-25
March, 2002 EIR Bayer AG - EIR, 2002-04-29
October, 2002 FDA 483 Response Shanghai Medicinal Ltd. No. 15 Pharmaceutical Factory - Form 483R, 2002-12-09
August, 2004 EIR Amneal Pharmaceuticals of New York, LLC - EIR, 2004-08-02
March, 2012 EIR Altaire Pharmaceuticals Inc. - EIR, 2012-03-19
October, 2002 EIR P & L Development, LLC - EIR, 2002-10-02
October, 2000 EIR Sun Pharmaceutical Industries Limited - EIR, 2000-10-20
September, 2014 FDA 483 Bristol-Myers Squibb Co., Inc. - Form 483, 2014-09-25
December, 2016 FDA 483 ASCENT CONSUMER PRODUCTS, INC. - Form 483, 2016-12-02
June, 2005 FDA 483 American Regent, Inc. - Form 483, 2005-06-27
February, 2017 EIR GRAXCELL PHARMACEUTICAL, LLC. - EIR, 2017-02-21
September, 2005 EIR Chartwell Pharmaceuticals Amityville, LLC. - EIR, 2005-09-09
May, 2006 FDA 483 Royal Labs - Form 483, 2006-05-19
November, 2012 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2012-11-16
July, 2009 FDA 483 Pedinol Pharmacal Inc - Form 483, 2009-07-23
October, 2001 FDA 483 Eight In One Pet Products, Inc - Form 483, 2001-10-03
January, 2014 FDA 483 LNK International, Inc. - Form 483, 2014-01-17
August, 2004 FDA 483 Advance Pharmaceutical, Inc. - Form 483, 2004-08-16
November, 2000 EIR Sun Pharmaceutical Industries Limited - EIR, 2000-11-02
May, 2000 EIR Fougera Pharmaceuticals Inc. - EIR, 2000-05-05
January, 2000 EIR Jerome Stevens Pharmaceuticals, Inc. - EIR, 2000-01-27
January, 2016 FDA 483 Brookhaven National Laboratory - Form 483, 2016-01-29
November, 2000 FDA 483 Dr. Reddy's Laboratories Limited - Form 483, 2000-11-09
March, 2014 FDA 483 Region Care, Inc. - Form 483, 2014-03-20
March, 2006 FDA 483 Sun Pharmaceutical Industries Limited - Form 483, 2006-03-02
March, 2015 FDA 483 POLYGEN PHARMACEUTICALS INC. - Form 483, 2015-03-24
April, 2017 EIR Amneal Pharmaceuticals of New York, LLC - EIR, 2017-04-11
December, 2001 FDA 483 Response Jetpharma SA - Form 483R, 2002-01-07
May, 2001 EIR Fougera Pharmaceuticals Inc. - EIR, 2001-05-02
October, 2007 FDA 483 Applied Genetics Inc. - Form 483, 2007-10-23
September, 2005 FDA 483 Chartwell Pharmaceuticals Amityville, LLC. - Form 483, 2005-09-09
November, 2012 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2012-11-16
September, 2003 FDA 483 Madcar A Division of Century Direct LLC - Form 483, 2003-09-26
July, 2012 FDA 483 Bristol-Myers Squibb Co., Inc. - Form 483, 2012-07-20
March, 2017 EIR Altaire Pharmaceuticals Inc. - EIR, 2017-03-09
February, 2010 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2010-02-04
October, 2014 FDA 483 American Regent, Inc. - Form 483, 2014-10-29
April, 2013 FDA 483 ABBE Laboratories, Inc. - Form 483, 2013-04-12
October, 2003 FDA 483 Takeda Pharmaceutical Company Limited - Form 483, 2003-10-24
February, 2000 FDA 483 Response DR. REDDY'S LABORATORIES LIMITED - Form 483R, 2000-03-16
June, 2016 FDA 483 Kings Park Slope Inc - Form 483, 2016-04-22
August, 2004 FDA 483 Response Amneal Pharmaceuticals of New York, LLC - Form 483R, 2004-08-31
August, 2016 EIR Regeneron Pharmaceuticals, Inc. - EIR, 2016-08-19
August, 2003 FDA 483 Allegiant Health - Form 483, 2003-08-22
February, 2000 EIR DR. REDDY'S LABORATORIES LIMITED - EIR, 2000-04-04
May, 2015 EIR InvaGen Pharmaceuticals, Inc - EIR, 2015-05-26
May, 2013 EIR Excella GmbH & Co. KG - EIR, 2013-05-17
May, 2002 EIR United Pet Group, Inc. - EIR, 2002-06-11
March, 2001 EIR Fougera Pharmaceuticals Inc. - EIR, 2001-03-13
August, 2004 EIR Advance Pharmaceutical, Inc. - EIR, 2004-08-16
October, 2006 EIR TIME CAP LABORATORIES, INC - EIR, 2006-10-03
March, 2017 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2017-03-09
May, 2011 FDA 483 Allegiant Health - Form 483, 2011-05-13
July, 2011 FDA 483 United-Guardian, Inc. - Form 483, 2011-07-22
March, 2010 FDA 483 Jerome Stevens Pharmaceuticals, Inc. - Form 483, 2010-03-10
June, 2001 EIR Zhejiang Kangle Pharmaceutical Co., Ltd. - EIR, 2001-06-02
June, 2000 EIR American Regent, Inc. - EIR, 2000-06-16
August, 2012 FDA 483 P & L Development, LLC - Form 483, 2012-08-24
November, 2017 FDA 483 PETNET SOLUTIONS, INC. - Form 483, 2017-11-15
September, 2011 FDA 483 ScieGen Pharmaceuticals, INC. - Form 483, 2011-09-16
February, 2012 FDA 483 Topiderm, Inc. - Form 483, 2012-02-24
March, 2010 FDA 483 Regeneron Pharmaceuticals, Inc. - Form 483, 2010-03-31
October, 2010 FDA 483 American Regent, Inc. - Form 483, 2010-10-29
November, 2016 FDA 483 TANGRAM CHEMICAL, LLC - Form 483, 2016-11-01
February, 2006 FDA 483 Sun Pharmaceutical Industries Limited - Form 483, 2006-02-25
January, 2006 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2006-01-05
May, 2014 FDA 483 Amneal Pharmaceuticals of New York, LLC - Form 483, 2014-05-16
January, 2007 FDA 483 InvaGen Pharmaceuticals, Inc - Form 483, 2007-01-19
January, 2000 FDA 483 Jerome Stevens Pharmaceuticals, Inc. - Form 483, 2000-01-27
June, 2009 EIR Akorn Operating Company LLC (dba Akorn) - EIR, 2009-06-12
October, 2003 EIR Takeda Pharmaceutical Company Limited - EIR, 2003-12-18
July, 2008 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2008-07-02
February, 2000 EIR DR. REDDY'S LABORATORIES LIMITED - EIR, 2000-04-17
October, 2002 FDA 483 Changzhou Pharmaceutical Factory - Form 483, 2002-10-31
April, 2015 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2015-04-13
October, 2010 EIR American Regent, Inc. - EIR, 2010-10-29
November, 2011 FDA 483 TIME CAP LABORATORIES, INC - Form 483, 2011-11-18
August, 2006 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2006-08-10
October, 2006 FDA 483 TIME CAP LABORATORIES, INC - Form 483, 2006-10-03
October, 2002 FDA 483 Response Changzhou Pharmaceutical Factory - Form 483R, 2002-12-30
November, 2010 EIR Altaire Pharmaceuticals Inc. - EIR, 2010-11-19
October, 2001 EIR United Pet Group, Inc. - EIR, 2001-10-03
May, 2011 FDA 483 Contract Pharmacal Corp. - Form 483, 2011-05-20
November, 2000 EIR Dr. Reddy's Laboratories Limited - EIR, 2000-11-09
July, 2013 FDA 483 Amneal Pharmaceuticals of New York, LLC - Form 483, 2013-07-03
February, 2009 FDA 483 CIPLA LIMITED - Form 483, 2009-02-06
March, 2018 FDA 483 TIME CAP LABORATORIES, INC - Form 483, 2018-03-12
March, 2003 EIR LUPIN LIMITED - EIR, 2003-03-24
December, 2001 EIR Jetpharma SA - EIR, 2001-12-06
November, 2015 FDA 483 Ascent Pharmaceuticals Inc - Form 483, 2015-11-09
July, 2013 EIR Amneal Pharmaceuticals of New York, LLC - EIR, 2013-07-03
November, 2000 FDA 483 Sun Pharmaceutical Industries Limited - Form 483, 2000-11-02
June, 2014 FDA 483 Response Regeneron Pharmaceuticals, Inc. - Form 483R, 2014-06-26
April, 2011 FDA 483 InvaGen Pharmaceuticals, Inc - Form 483, 2011-04-13
April, 2013 EIR ScieGen Pharmaceuticals, INC. - EIR, 2013-04-02
October, 2002 EIR Changzhou Pharmaceutical Factory - EIR, 2002-10-31
October, 2002 FDA 483 Sichuan Long March Pharmaceutical Co. Ltd. - Form 483, 2002-10-25
October, 2001 FDA 483 Response Eight In One Pet Products, Inc - Form 483R, 2001-11-19
August, 2004 FDA 483 Amneal Pharmaceuticals of New York, LLC - Form 483, 2004-08-02
March, 2002 FDA 483 Bayer Pharma AG - Form 483, 2002-03-08
October, 2015 FDA 483 ONY Biotech Inc. - Form 483, 2015-10-09
June, 2012 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2012-06-11
October, 2003 FDA 483 Shanghai No15 Pham Factory - Form 483, 2003-10-31
April, 2002 FDA 483 Response American Regent, Inc. - Form 483R, 2002-05-13
August, 2007 EIR American Regent, Inc. - EIR, 2007-08-03
June, 2015 EIR Biogen, Inc. - EIR, 2015-06-26
September, 2013 EIR ScieGen Pharmaceuticals, INC. - EIR, 2013-09-18
October, 2002 EIR Shanghai Medicinal Ltd. No. 15 Pharmaceutical Factory - EIR, 2002-10-17
June, 2017 FDA 483 Infusion Options, Inc. - Form 483, 2017-06-01
June, 2014 EIR Regeneron Pharmaceuticals, Inc. - EIR, 2014-06-13
March, 2001 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2001-03-13
June, 2005 EIR American Regent, Inc. - EIR, 2005-06-27
April, 2012 FDA 483 SpecGx LLC - Form 483, 2012-04-20
May, 2000 FDA 483 Response Fougera Pharmaceuticals Inc. - Form 483R, 2000-05-17
February, 2010 EIR Altaire Pharmaceuticals Inc. - EIR, 2010-02-04
February, 2000 FDA 483 Response DR. REDDY'S LABORATORIES LIMITED - Form 483R, 2000-03-13
April, 2018 FDA 483 American Regent, Inc. - Form 483, 2018-04-11
May, 2006 FDA 483 PDK Labs, Inc - Form 483, 2006-05-12
June, 2005 FDA 483 Response American Regent, Inc. - Form 483R, 2005-07-06
May, 2001 FDA 483 Response KAKEN Pharmaceutical Co., LTD - Form 483R, 2001-06-27
August, 2012 EIR P & L Development, LLC - EIR, 2012-08-24
August, 2016 FDA 483 Regeneron Pharmaceuticals, Inc. - Form 483, 2016-08-19
May, 2001 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2001-05-02
March, 2003 FDA 483 Response LUPIN LIMITED - Form 483R, 2003-04-11
March, 2013 FDA 483 InvaGen Pharmaceuticals, Inc - Form 483, 2013-03-08
July, 2003 FDA 483 Amneal Pharmaceuticals of New York, LLC - Form 483, 2003-07-08
May, 2000 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2000-05-05
July, 2016 FDA 483 Queens Express Pharmacy - Form 483, 2016-07-11
January, 2015 FDA 483 ScieGen Pharmaceuticals, INC. - Form 483, 2015-01-09
May, 2002 FDA 483 United Pet Group, Inc. - Form 483, 2002-05-24
September, 2000 FDA 483 Chartwell Pharmaceuticals Amityville, LLC. - Form 483, 2000-09-05
October, 2011 FDA 483 Chartwell Pharmaceuticals Amityville, LLC. - Form 483, 2011-10-19
August, 2014 FDA 483 Alexion Pharmaceuticals, Inc. - Form 483, 2014-08-22
October, 2002 FDA 483 P & L Development, LLC - Form 483, 2002-10-02

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