FDA Investigator Dr. Robert C Horan, MD

Dr. Robert C Horan, MD has conducted inspections on 230 sites in 10 countries as of 19 Mar 2018. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
230
Last Inspection Date:
19 Mar 2018
Investigator Role:
FDA Investigator
Redica ID:
100000104
Countries of Inspections:
United States of America, China, Germany, India, Switzerland, United Kingdom of Great Britain and Northern Ireland, Australia, Japan, Singapore, Korea (Republic of)
FDA Investigators that have inspected at least one site in common with Dr. Robert C Horan, MD:
Ademola O Daramola, Adena S Yau, Adetutu M Gidado, Aditi S Thakur, Alan P Kurtzberg, Alberto A Viciedo, Albinus M D'sa, Alia Legaux, Alice S Tsao, Alicia M Mozzachio, Althea A Williams, Amatul H Marium, Amy N Chen, Amy Wyan Mai, Anastasia M Shields, Andrew J Garufi, Andrew M Abramowitz, Angela E Glenn, Angela 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 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 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, Concepcion Cruz, Jr, Cynthia J Lee, MS, Cynthia Jim, CSO, Cynthia Whitmarsh, 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, Dr. Willie Wilson, PhD, Edecia A Richards, Edmund F Mrak, Jr, Edouard Viard, Ellen C Weisensel, Ellen P Madigan, Erica B Brush, Erica B Raphael, Erika E Englund, PhD, Erika V Butler, Erin L Nagel, Farhana Khan, Feiyan Jin, Felix Maldonado, Francis A Guidry, Frank Verni, Frederick F Razzaghi, Gam S Zamil, Ganesh N Joshi, Gary J Hagan, 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 L Negron, J Paul Kirwan, PhD, Jacek Cieslak, PhD, Jackson Y See, 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 A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose M Cayuela, Jose Ohernandez Guzman, Jose R Hernandez, Joseph A Piechocki, Joseph F Mcginnis, RPh, Joseph J Vannelli, Joseph Maselli, 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, 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, Lewis K Antwi, Li Yun Huang, Liatte Kreuger, PharmD, Linda M Sacco, Lisa R Hilliar, Lori A Holmquist, Lori M Newman, LT Colin E Tack, BSE, Lucas B Leake, Luis A Dasta, Lynda L Perry, PhD, M A Abel I, 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 B Buen 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 Yclark Stuart, Miguel A Martinez Perez, Mihaly S Ligmond, Milos Dokmanovic, PhD, Mindy M Chou, Miral B Patel, Mra Davism, Mra Digiuliod, Mra M Barbosar, Mra Mcculloughj, Mra V Millarw, 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 Muñiz, Obinna R Echeozo, Ogechi C Nna, Omadevi Somai, Investigator, Omotunde O Osunsanmi, Otto D Vitillo, Paige R Mccoy, Pankaj H Amin, Paraluman S Leonin, Parul M Patel, Patricia F Hughes, PhD, 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, Priscilla M Pastrana, Rachael A Moliver, Rachael L Cook, Raihan A Chowdhury, 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 L Friedman, Richard L Rutherford, Richard Ledwidge (nmi), PhD, Richard W Thornton, Rita K Kabaso, Robert C Howard, Robert C Steyert, Robert D Tollefsen, Robert J Martin, Robert J Veitch, Robert O'brian, Rochelle K Kimmel, Rochelle L Cross, Roger F Zabinski, Ronald Ifraimov, Rory K Geyer, Rose Ashley, Rose Xu, Roseline N Boateng, Russ E Davis, Russell J Glapion, Russell K Riley, Saleem A Akhtar, 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, Saundrea A Munroe, Sayyem H Akbar, Scott B Laufenberg, Scott R Nichols, PhD, Scott T Ballard, Sean R Marcsisin, Shafiq S Ahadi, Shari L Kahn, Sharon K Thoma, PharmD, 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 T Hadman, Susan W Ting, Susanna E Ford, Suwaskie S Smith, Svetlana A Shestopal, Syed N Ali, Syeda N Mahazabin, Taichun Qin, PhD, Tamil Arasu, PhD, 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 S Savage, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, 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, Vijaya L Simhadri, 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, 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
May, 2001 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2001-05-02
September, 2000 FDA 483 Chartwell Pharmaceuticals Amityville, LLC. - Form 483, 2000-09-05
July, 2009 FDA 483 Pedinol Pharmacal Inc - Form 483, 2009-07-23
January, 2016 FDA 483 Brookhaven National Laboratory - Form 483, 2016-01-29
May, 2000 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2000-05-05
January, 2015 FDA 483 ScieGen Pharmaceuticals INC - Form 483, 2015-01-09
August, 2004 EIR Advance Pharmaceutical, Inc. - EIR, 2004-08-16
May, 2002 FDA 483 United Pet Group, Inc. - Form 483, 2002-05-24
October, 2002 EIR Changzhou Pharmaceutical Factory - EIR, 2002-10-31
June, 2005 FDA 483 American Regent, Inc. - Form 483, 2005-06-27
February, 2000 FDA 483 Response Dr Reddy's Laboratories Limited - Form 483R, 2000-03-16
June, 2001 EIR Zhejiang Kangle Pharmaceutical Co., Ltd. - EIR, 2001-06-02
February, 2000 FDA 483 Dr Reddy's Laboratories Limited - Form 483, 2000-02-16
April, 2013 FDA 483 ABBE Laboratories, Inc. - Form 483, 2013-04-12
August, 2004 FDA 483 Amneal Pharmaceuticals of New York, LLC - Form 483, 2004-08-02
March, 2012 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2012-03-19
March, 2001 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2001-03-13
March, 2002 EIR Bayer AG - EIR, 2002-04-29
April, 2013 EIR ScieGen Pharmaceuticals INC - EIR, 2013-04-02
October, 2015 FDA 483 ONY Biotech Inc. - Form 483, 2015-10-09
March, 2018 FDA 483 TIME CAP LABORATORIES, INC - Form 483, 2018-03-12
December, 2001 EIR Jetpharma SA - EIR, 2001-12-06
October, 2007 FDA 483 Applied Genetics Inc. - Form 483, 2007-10-23
July, 2013 EIR Amneal Pharmaceuticals of New York, LLC - EIR, 2013-07-03
July, 2003 FDA 483 Amneal Pharmaceuticals of New York, LLC - Form 483, 2003-07-08
July, 2011 FDA 483 United-Guardian, Inc. - Form 483, 2011-07-22
October, 2014 FDA 483 American Regent, Inc. - Form 483, 2014-10-29
October, 2011 FDA 483 Chartwell Pharmaceuticals Amityville, LLC. - Form 483, 2011-10-19
October, 2006 FDA 483 TIME CAP LABORATORIES, INC - Form 483, 2006-10-03
February, 2006 FDA 483 Sun Pharmaceutical Industries Limited - Form 483, 2006-02-25
June, 2006 FDA 483 American Regent, Inc. - Form 483, 2006-06-16
January, 2007 FDA 483 InvaGen Pharmaceuticals, Inc - Form 483, 2007-01-19
May, 2000 FDA 483 Response Fougera Pharmaceuticals Inc. - Form 483R, 2000-05-17
October, 2002 EIR Sichuan Long March Pharmaceutical Co. Ltd. - EIR, 2002-10-25
October, 2002 EIR P & L Development, LLC - EIR, 2002-10-02
February, 2000 FDA 483 Response DR REDDY'S LABORATORIES LIMITED - Form 483R, 2000-03-13
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
August, 2014 FDA 483 Alexion Pharmaceuticals, Inc. - Form 483, 2014-08-22
October, 2002 FDA 483 Response Shanghai Medicinal Ltd. No. 15 Pharmaceutical Factory - Form 483R, 2002-12-09
March, 2012 EIR Altaire Pharmaceuticals Inc. - EIR, 2012-03-19
May, 2006 FDA 483 PDK Labs, Inc - Form 483, 2006-05-12
May, 2001 EIR Fougera Pharmaceuticals Inc. - EIR, 2001-05-02
March, 2003 FDA 483 Response LUPIN LIMITED - Form 483R, 2003-04-11
May, 2014 FDA 483 Amneal Pharmaceuticals of New York, LLC - Form 483, 2014-05-16
May, 2015 FDA 483 InvaGen Pharmaceuticals, Inc - Form 483, 2015-05-26
June, 2000 FDA 483 American Regent, Inc. - Form 483, 2000-06-16
October, 2006 EIR TIME CAP LABORATORIES, INC - EIR, 2006-10-03
August, 2012 EIR P & L Development, LLC - EIR, 2012-08-24
March, 2013 FDA 483 InvaGen Pharmaceuticals, Inc - Form 483, 2013-03-08
July, 2016 FDA 483 Queens Express Pharmacy - Form 483, 2016-07-11
March, 2015 FDA 483 POLYGEN PHARMACEUTICALS INC. - Form 483, 2015-03-24
March, 2002 FDA 483 Bayer AG - Form 483, 2002-03-20
December, 2015 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2015-12-15
July, 2012 FDA 483 Bristol-Myers Squibb Co., Inc. - Form 483, 2012-07-20
October, 2002 FDA 483 Response Sichuan Long March Pharmaceutical Co. Ltd. - Form 483R, 2002-11-20
December, 2011 FDA 483 Advance Pharmaceutical, Inc. - Form 483, 2011-12-16
March, 2006 FDA 483 Sun Pharmaceutical Industries Limited - Form 483, 2006-03-02
April, 2002 EIR American Regent, Inc. - EIR, 2002-04-30
March, 2003 FDA 483 LUPIN LIMITED - Form 483, 2003-03-24
June, 2016 FDA 483 Kings Park Slope Inc - Form 483, 2016-04-22
March, 2014 FDA 483 Region Care, Inc. - Form 483, 2014-03-20
October, 2001 FDA 483 Eight In One Pet Products, Inc - Form 483, 2001-10-03
December, 2001 FDA 483 Response Jetpharma SA - Form 483R, 2002-01-07
November, 2000 FDA 483 Sun Pharmaceutical Industries Limited - Form 483, 2000-11-02
January, 2014 FDA 483 LNK International, Inc. - Form 483, 2014-01-17
June, 2014 FDA 483 Response Regeneron Pharmaceuticals, Inc. - Form 483R, 2014-06-26
March, 2017 EIR Altaire Pharmaceuticals Inc. - EIR, 2017-03-09
April, 2009 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2009-04-28
May, 2006 FDA 483 Royal Labs - Form 483, 2006-05-19
May, 2001 FDA 483 Response Fougera Pharmaceuticals Inc. - Form 483R, 2001-05-08
September, 2005 EIR Chartwell Pharmaceuticals Amityville, LLC. - EIR, 2005-09-09
January, 2018 FDA 483 Amneal Pharmaceuticals of New York, LLC - Form 483, 2018-01-18
May, 2001 FDA 483 KAKEN Pharmaceutical Co., LTD - Form 483, 2001-05-18
May, 2002 FDA 483 Response United Pet Group, Inc. - Form 483R, 2002-06-04
July, 2014 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2014-07-29
April, 2017 FDA 483 Lotte Biologics USA, LLC - Form 483, 2017-04-28
May, 2001 EIR KAKEN Pharmaceutical Co., LTD - EIR, 2001-07-11
March, 2002 FDA 483 Response Bayer AG - Form 483R, 2002-04-19
February, 2015 FDA 483 Lonza Biologics, Inc. - Form 483, 2015-02-10
November, 2010 FDA 483 Chartwell Pharmaceuticals Amityville, LLC. - Form 483, 2010-11-12
October, 2000 EIR Sun Pharmaceutical Industries Limited - EIR, 2000-10-27
August, 2013 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2013-08-08
November, 2000 EIR Sun Pharmaceutical Industries Limited - EIR, 2000-11-02
November, 2012 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2012-11-16
May, 2001 EIR MSD International GmbH (Singapore Branch) - EIR, 2001-07-13
June, 2015 FDA 483 Biogen, Inc. - Form 483, 2015-06-26
October, 2002 FDA 483 P & L Development, LLC - Form 483, 2002-10-02
December, 2017 FDA 483 Kreitchman PET Center - Form 483, 2017-12-15
October, 2003 FDA 483 Response Shanghai Medicinal Ltd. No. 15 Pharmaceutical Factory - Form 483R, 2003-11-10
October, 2003 EIR Shanghai Medicinal Ltd. No. 15 Pharmaceutical Factory - EIR, 2003-12-09
April, 2011 FDA 483 InvaGen Pharmaceuticals, Inc - Form 483, 2011-04-13
May, 2015 EIR InvaGen Pharmaceuticals, Inc - EIR, 2015-05-26
March, 2017 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2017-03-09
August, 2004 EIR Amneal Pharmaceuticals of New York, LLC - EIR, 2004-08-02
October, 2000 FDA 483 Sun Pharmaceutical Industries Limited - Form 483, 2000-10-20
August, 2016 FDA 483 Response Regeneron Pharmaceuticals, Inc. - Form 483R, 2016-09-08
February, 2017 EIR GRAXCELL PHARMACEUTICAL, LLC. - EIR, 2017-02-21
June, 2006 EIR American Regent, Inc. - EIR, 2006-06-16
August, 2004 FDA 483 Advance Pharmaceutical, Inc. - Form 483, 2004-08-16
October, 2002 EIR Shanghai Medicinal Ltd. No. 15 Pharmaceutical Factory - EIR, 2002-10-17
June, 2012 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2012-06-11
August, 2006 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2006-08-10
April, 2008 FDA 483 Bristol-Myers Squibb Co., Inc. - Form 483, 2008-04-18
April, 2017 EIR Amneal Pharmaceuticals of New York, LLC - EIR, 2017-04-11
September, 2013 EIR ScieGen Pharmaceuticals INC - EIR, 2013-09-18
November, 2012 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2012-11-16
June, 2000 EIR American Regent, Inc. - EIR, 2000-06-16
October, 2001 EIR United Pet Group, Inc. - EIR, 2001-10-03
September, 2011 FDA 483 ScieGen Pharmaceuticals INC - Form 483, 2011-09-16
November, 2000 FDA 483 Response Dr. Reddy's Laboratories Limited - Form 483R, 2000-11-23
October, 2000 FDA 483 Sun Pharmaceutical Industries Limited - Form 483, 2000-10-27
September, 2003 FDA 483 Madcar A Division of Century Direct Solutions - Form 483, 2003-09-26
August, 2003 FDA 483 Allegiant Health - Form 483, 2003-08-22
May, 2011 FDA 483 Allegiant Health - Form 483, 2011-05-13
June, 2017 FDA 483 Infusion Options, Inc. - Form 483, 2017-06-01
March, 2001 EIR Fougera Pharmaceuticals Inc. - EIR, 2001-03-13
April, 2018 FDA 483 American Regent, Inc. - Form 483, 2018-04-11
March, 2010 FDA 483 Jerome Stevens Pharmaceuticals, Inc. - Form 483, 2010-03-10
September, 2005 FDA 483 Chartwell Pharmaceuticals Amityville, LLC. - Form 483, 2005-09-09
October, 2002 FDA 483 Response Changzhou Pharmaceutical Factory - Form 483R, 2002-12-30
August, 2004 FDA 483 Response Amneal Pharmaceuticals of New York, LLC - Form 483R, 2004-08-31
November, 2000 FDA 483 Dr. Reddy's Laboratories Limited - Form 483, 2000-11-09
May, 2011 FDA 483 Contract Pharmacal Corp. - Form 483, 2011-05-20
November, 2010 EIR Altaire Pharmaceuticals Inc. - EIR, 2010-11-19
June, 2009 EIR Akorn Operating Company LLC (dba Akorn) - EIR, 2009-06-12
October, 2002 FDA 483 Shanghai Medicinal Ltd. No. 15 Pharmaceutical Factory - Form 483, 2002-10-17
June, 2000 FDA 483 Response American Regent, Inc. - Form 483R, 2000-06-30
July, 2008 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2008-07-02
April, 2015 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2015-04-13
November, 2015 FDA 483 Ascent Pharmaceuticals Inc - Form 483, 2015-11-09
June, 2006 FDA 483 Generic Pharmaceutical Services inc. - Form 483, 2006-06-29
October, 2010 EIR American Regent, Inc. - EIR, 2010-10-29
May, 1998 FDA 483 TIME CAP LABORATORIES, INC - Form 483, 1998-05-05
August, 2007 EIR American Regent, Inc. - EIR, 2007-08-03
December, 2001 FDA 483 Jetpharma SA - Form 483, 2001-12-06
February, 2012 FDA 483 Topiderm, Inc. - Form 483, 2012-02-24
August, 2016 FDA 483 Regeneron Pharmaceuticals, Inc. - Form 483, 2016-08-19
June, 2014 FDA 483 Regeneron Pharmaceuticals, Inc. - Form 483, 2014-06-13
September, 2000 EIR Chartwell Pharmaceuticals Amityville, LLC. - EIR, 2000-09-05
June, 2014 EIR Regeneron Pharmaceuticals, Inc. - EIR, 2014-06-13
July, 2017 FDA 483 Advance Pharmaceutical, Inc. - Form 483, 2017-07-06
December, 2016 FDA 483 ASCENT CONSUMER PRODUCTS, INC. - Form 483, 2016-12-02
July, 2010 FDA 483 Qilu Pharmaceutical Co., Ltd. - Form 483, 2010-07-01
February, 2007 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2007-02-07
August, 2012 FDA 483 P & L Development, LLC - Form 483, 2012-08-24
January, 2000 EIR Jerome Stevens Pharmaceuticals, Inc. - EIR, 2000-01-27
April, 2002 FDA 483 American Regent, Inc. - Form 483, 2002-04-30
August, 2007 FDA 483 American Regent, Inc. - Form 483, 2007-08-03
May, 2013 EIR Excella GmbH & Co. KG - EIR, 2013-05-17
October, 2010 FDA 483 Response American Regent, Inc. - Form 483R, 2010-11-19
May, 2000 EIR Fougera Pharmaceuticals Inc. - EIR, 2000-05-05
January, 2000 FDA 483 Jerome Stevens Pharmaceuticals, Inc. - Form 483, 2000-01-27
October, 2003 FDA 483 Takeda Pharmaceutical Company Limited - Form 483, 2003-10-24
February, 2009 FDA 483 Cipla Ltd. - Form 483, 2009-02-06
November, 2000 EIR Dr. Reddy's Laboratories Limited - EIR, 2000-11-09
June, 2011 FDA 483 MANA PRODUCTS, INC. - Form 483, 2011-06-23
October, 2003 EIR Takeda Pharmaceutical Company Limited - EIR, 2003-12-18
August, 2007 FDA 483 Response American Regent, Inc. - Form 483R, 2007-08-17
June, 2005 EIR American Regent, Inc. - EIR, 2005-06-27
March, 2003 EIR LUPIN LIMITED - EIR, 2003-03-24
October, 2001 FDA 483 Response Eight In One Pet Products, Inc - Form 483R, 2001-11-19
December, 2007 FDA 483 DPT Lakewood, Inc. - Form 483, 2007-12-05
April, 2002 FDA 483 Response American Regent, Inc. - Form 483R, 2002-05-13
June, 2005 FDA 483 Response American Regent, Inc. - Form 483R, 2005-07-06
November, 2011 FDA 483 TIME CAP LABORATORIES, INC - Form 483, 2011-11-18
March, 2002 FDA 483 Bayer Pharma AG - Form 483, 2002-03-08
April, 2017 FDA 483 Amneal Pharmaceuticals of New York, LLC - Form 483, 2017-04-11
October, 2002 FDA 483 Sichuan Long March Pharmaceutical Co. Ltd. - Form 483, 2002-10-25
February, 2010 EIR Altaire Pharmaceuticals Inc. - EIR, 2010-02-04
October, 2000 FDA 483 Response Sun Pharmaceutical Industries Limited - Form 483R, 2000-12-04
December, 2013 FDA 483 Advance Pharmaceutical, Inc. - Form 483, 2013-12-19
April, 2012 FDA 483 SpecGx LLC - Form 483, 2012-04-20
June, 2015 EIR Biogen, Inc. - EIR, 2015-06-26
October, 2012 FDA 483 Busse Hospital Disposables, Inc. - Form 483, 2012-10-25
February, 2010 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2010-02-04
June, 2001 FDA 483 Response Zhejiang Kangle Pharmaceutical Co., Ltd. - Form 483R, 2001-06-12
March, 2010 FDA 483 Regeneron Pharmaceuticals, Inc. - Form 483, 2010-03-31
October, 2010 FDA 483 American Regent, Inc. - Form 483, 2010-10-29
January, 2006 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2006-01-05
November, 2000 FDA 483 Response Sun Pharmaceutical Industries Limited - Form 483R, 2000-11-28
November, 2010 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2010-11-19
February, 2000 EIR DR REDDY'S LABORATORIES LIMITED - EIR, 2000-04-04
May, 2002 EIR United Pet Group, Inc. - EIR, 2002-06-11
February, 2000 EIR Dr Reddy's Laboratories Limited - EIR, 2000-04-17
March, 2001 FDA 483 Response Fougera Pharmaceuticals Inc. - Form 483R, 2001-04-03
November, 2016 FDA 483 TANGRAM CHEMICAL, LLC - Form 483, 2016-11-01
July, 2013 FDA 483 Amneal Pharmaceuticals of New York, LLC - Form 483, 2013-07-03
August, 2016 EIR Regeneron Pharmaceuticals, Inc. - EIR, 2016-08-19
October, 2002 FDA 483 Changzhou Pharmaceutical Factory - Form 483, 2002-10-31
November, 2017 FDA 483 PETNET SOLUTIONS, INC. - Form 483, 2017-11-15
May, 2001 FDA 483 Response KAKEN Pharmaceutical Co., LTD - Form 483R, 2001-06-27
October, 2003 FDA 483 Shanghai Medicinal Ltd. No. 15 Pharmaceutical Factory - Form 483, 2003-10-31

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